Regulatory Open Forum

Dear All

In the past I placed medical devices on the EU market. However, now I'm confronted with systems of accessories. So hence, my questions (3).

If I develop a system that has a medical purpose and consists of products, of which none can be claimed by itself to be a medical device as it needs the others (see MDR Art 2 (1, 2)), based on what do I select the one that is the "medical device" and, therefore, the other ones to be its accessories? Do I simply choose the "brain", which coordinates the usage, or do I pick any other "important" product?

Once I decided on the accessories and develop them with their own Declaration of Conformity (DoC), how do I handle the clinical side of the technical documentation (risk management, clinical evalation)? By the MDR concept, accessories have no medical purpose, but are classified as medical devices. Do I stick with the wording of the MDR and say their medical purpose is to enable the medical device?

And thirdly, as I know companies with DoCs containing only accessories, what are the pros & cons of separating their DoCs from those of the medical devices that use them?

I apologize for the density of my questions. It is only because I'm unable to find the answers.

Thank you so much,
Richard

------------------------------
Richard Jansky
Head of RA / RM / QM
Beringen
Switzerland
------------------------------

Several remarks that may help to untangle this knot for you:

• Accessories are not classified as medical devices but as 'devices', the overarching concept of 'regulated subject matter' under the MDR, covering medical devices, accessories and Annex XVI devices ('non-medical devices').
• A medical device that 'needs' another device is not an accessory as you seem to state, but may also be a compatible or interoperable medical device (see Annex I, point 14.5). Rather with accessory qualification it is the other way around from how you seem to approach it: the device that acts as an accessory to a medical device is the accessory (see the definition in the MDR), not a device that 'needs' another device or product.
• There is nothing in the text of article 22 (1) MDR to prevent you from assembling a system of accessories, because the text does not require that there is a 'main medical device' around which the system revolves or something ("combine devices bearing a CE marking with the following other devices or products, in a manner that is compatible with the intended purpose of the devices or other products and within the limits of use specified by their manufacturers, in order to place them on the market as a system")(underlining added)

Maybe rethink with this in mind and see if that changes your conclusion. And otherwise, maybe provide more information about the actual products - allows for better feedback.

Good luck!

------------------------------
Erik Vollebregt
Partner
Amsterdam
Netherlands
------------------------------

Original Message:
Sent: 03-Feb-2022 07:05
From: Richard Jansky
Subject: Handling a System of Accessories

Dear All

In the past I placed medical devices on the EU market. However, now I'm confronted with systems of accessories. So hence, my questions (3).

If I develop a system that has a medical purpose and consists of products, of which none can be claimed by itself to be a medical device as it needs the others (see MDR Art 2 (1, 2)), based on what do I select the one that is the "medical device" and, therefore, the other ones to be its accessories? Do I simply choose the "brain", which coordinates the usage, or do I pick any other "important" product?

Once I decided on the accessories and develop them with their own Declaration of Conformity (DoC), how do I handle the clinical side of the technical documentation (risk management, clinical evalation)? By the MDR concept, accessories have no medical purpose, but are classified as medical devices. Do I stick with the wording of the MDR and say their medical purpose is to enable the medical device?

And thirdly, as I know companies with DoCs containing only accessories, what are the pros & cons of separating their DoCs from those of the medical devices that use them?

I apologize for the density of my questions. It is only because I'm unable to find the answers.

Thank you so much,
Richard

------------------------------
Richard Jansky
Head of RA / RM / QM
Beringen
Switzerland
------------------------------

Hello Richard,

Accessories is a confusion topic and can be highly debatable subject within regulatory circles.  There are accessories which can work with many medical devices, accessories which only work with one device manufacturer product, accessories which are optional, accessories which are not medical devices in of themselves even when connected to a medical device, so there are many variations.  The best approach is within the technical documentation clearly define the "medical device" and the accessories including how they are all used together, what is needed, what function they perform, and how the interaction with the medical device is done.  As an example, I worked on a type of endoscope product where there was a "holder" that connected the endoscope equipment to the surgery bed/location.  It was completely optional just to help the physician, kind of giving a helping hand.  The company called it an accessory (optional), the Notified Body reviewer did not agree stating it needed to be removed, long story short - there was a long, long discussion about this "accessory" which was a configured metal part not contributing at all to the intended purpose of the device which caused a lot of angst.

For your first question, it is up to the manufacturer to define the "system" including all the main component, accessories, components, etc., so it should be clearly defined within the Technical Documentation as to what you referred to as the "brain" and then all the components/modules/accessories which are part of the medical device.  As mentioned previously and by Erik, accessories are not always medical devices and accessories can be classified in their own right as well.  There just may not be full consensus or agreement by a Notified Body so make sure there is a good rationale and decision process.  Technical documentation, risk management, clinical evaluation, even post market reporting can be tricky with accessories.  Myself, I generally like to keep the accessories in the main product technical documentation, so all the information about the clinical aspect is maintained with the main medical device.  For the final question, separate Technical Documentation file and therefore a separate Declaration of Conformity (DofC) also can be tricky.  Myself again, the Tech Doc and DofC (if you make separate for many accessories) does not really live "on its own" but the Tech Doc and DofC are sort of connected and/or sub-documents of the main technical documentation.  It can be a bit tricky, so make sure it all makes sense and can be clearly explained to an external party.

------------------------------
Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs
------------------------------

Original Message:
Sent: 04-Feb-2022 03:03
From: Erik Vollebregt
Subject: Handling a System of Accessories

Several remarks that may help to untangle this knot for you:

• Accessories are not classified as medical devices but as 'devices', the overarching concept of 'regulated subject matter' under the MDR, covering medical devices, accessories and Annex XVI devices ('non-medical devices').
• A medical device that 'needs' another device is not an accessory as you seem to state, but may also be a compatible or interoperable medical device (see Annex I, point 14.5). Rather with accessory qualification it is the other way around from how you seem to approach it: the device that acts as an accessory to a medical device is the accessory (see the definition in the MDR), not a device that 'needs' another device or product.
• There is nothing in the text of article 22 (1) MDR to prevent you from assembling a system of accessories, because the text does not require that there is a 'main medical device' around which the system revolves or something ("combine devices bearing a CE marking with the following other devices or products, in a manner that is compatible with the intended purpose of the devices or other products and within the limits of use specified by their manufacturers, in order to place them on the market as a system")(underlining added)

Maybe rethink with this in mind and see if that changes your conclusion. And otherwise, maybe provide more information about the actual products - allows for better feedback.

Good luck!

------------------------------
Erik Vollebregt
Partner
Amsterdam
Netherlands

Original Message:
Sent: 03-Feb-2022 07:05
From: Richard Jansky
Subject: Handling a System of Accessories

Dear All

In the past I placed medical devices on the EU market. However, now I'm confronted with systems of accessories. So hence, my questions (3).

If I develop a system that has a medical purpose and consists of products, of which none can be claimed by itself to be a medical device as it needs the others (see MDR Art 2 (1, 2)), based on what do I select the one that is the "medical device" and, therefore, the other ones to be its accessories? Do I simply choose the "brain", which coordinates the usage, or do I pick any other "important" product?

Once I decided on the accessories and develop them with their own Declaration of Conformity (DoC), how do I handle the clinical side of the technical documentation (risk management, clinical evalation)? By the MDR concept, accessories have no medical purpose, but are classified as medical devices. Do I stick with the wording of the MDR and say their medical purpose is to enable the medical device?

And thirdly, as I know companies with DoCs containing only accessories, what are the pros & cons of separating their DoCs from those of the medical devices that use them?

I apologize for the density of my questions. It is only because I'm unable to find the answers.

Thank you so much,
Richard

------------------------------
Richard Jansky
Head of RA / RM / QM
Beringen
Switzerland
------------------------------

Thank you Richard

That is exactly my point.

From the RA point of view, it is easier to keep the system as one medical device (one Technical Documentation). If you split it, then how do you handle the clinical aspects on the accessory side and the system aspects on the medical product side (compatibility). And lastly, when you do split it, what is the advantage of all the effort.

Best regards,
Richard

------------------------------
Richard Jansky
Head of RA / RM / QM
Beringen
Switzerland
------------------------------

Original Message:
Sent: 04-Feb-2022 05:19
From: Richard Vincins
Subject: Handling a System of Accessories

Hello Richard,

Accessories is a confusion topic and can be highly debatable subject within regulatory circles.  There are accessories which can work with many medical devices, accessories which only work with one device manufacturer product, accessories which are optional, accessories which are not medical devices in of themselves even when connected to a medical device, so there are many variations.  The best approach is within the technical documentation clearly define the "medical device" and the accessories including how they are all used together, what is needed, what function they perform, and how the interaction with the medical device is done.  As an example, I worked on a type of endoscope product where there was a "holder" that connected the endoscope equipment to the surgery bed/location.  It was completely optional just to help the physician, kind of giving a helping hand.  The company called it an accessory (optional), the Notified Body reviewer did not agree stating it needed to be removed, long story short - there was a long, long discussion about this "accessory" which was a configured metal part not contributing at all to the intended purpose of the device which caused a lot of angst.

For your first question, it is up to the manufacturer to define the "system" including all the main component, accessories, components, etc., so it should be clearly defined within the Technical Documentation as to what you referred to as the "brain" and then all the components/modules/accessories which are part of the medical device.  As mentioned previously and by Erik, accessories are not always medical devices and accessories can be classified in their own right as well.  There just may not be full consensus or agreement by a Notified Body so make sure there is a good rationale and decision process.  Technical documentation, risk management, clinical evaluation, even post market reporting can be tricky with accessories.  Myself, I generally like to keep the accessories in the main product technical documentation, so all the information about the clinical aspect is maintained with the main medical device.  For the final question, separate Technical Documentation file and therefore a separate Declaration of Conformity (DofC) also can be tricky.  Myself again, the Tech Doc and DofC (if you make separate for many accessories) does not really live "on its own" but the Tech Doc and DofC are sort of connected and/or sub-documents of the main technical documentation.  It can be a bit tricky, so make sure it all makes sense and can be clearly explained to an external party.

------------------------------
Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs

Original Message:
Sent: 04-Feb-2022 03:03
From: Erik Vollebregt
Subject: Handling a System of Accessories

Several remarks that may help to untangle this knot for you:

• Accessories are not classified as medical devices but as 'devices', the overarching concept of 'regulated subject matter' under the MDR, covering medical devices, accessories and Annex XVI devices ('non-medical devices').
• A medical device that 'needs' another device is not an accessory as you seem to state, but may also be a compatible or interoperable medical device (see Annex I, point 14.5). Rather with accessory qualification it is the other way around from how you seem to approach it: the device that acts as an accessory to a medical device is the accessory (see the definition in the MDR), not a device that 'needs' another device or product.
• There is nothing in the text of article 22 (1) MDR to prevent you from assembling a system of accessories, because the text does not require that there is a 'main medical device' around which the system revolves or something ("combine devices bearing a CE marking with the following other devices or products, in a manner that is compatible with the intended purpose of the devices or other products and within the limits of use specified by their manufacturers, in order to place them on the market as a system")(underlining added)

Maybe rethink with this in mind and see if that changes your conclusion. And otherwise, maybe provide more information about the actual products - allows for better feedback.

Good luck!

------------------------------
Erik Vollebregt
Partner
Amsterdam
Netherlands

Original Message:
Sent: 03-Feb-2022 07:05
From: Richard Jansky
Subject: Handling a System of Accessories

Dear All

In the past I placed medical devices on the EU market. However, now I'm confronted with systems of accessories. So hence, my questions (3).

If I develop a system that has a medical purpose and consists of products, of which none can be claimed by itself to be a medical device as it needs the others (see MDR Art 2 (1, 2)), based on what do I select the one that is the "medical device" and, therefore, the other ones to be its accessories? Do I simply choose the "brain", which coordinates the usage, or do I pick any other "important" product?

Once I decided on the accessories and develop them with their own Declaration of Conformity (DoC), how do I handle the clinical side of the technical documentation (risk management, clinical evalation)? By the MDR concept, accessories have no medical purpose, but are classified as medical devices. Do I stick with the wording of the MDR and say their medical purpose is to enable the medical device?

And thirdly, as I know companies with DoCs containing only accessories, what are the pros & cons of separating their DoCs from those of the medical devices that use them?

I apologize for the density of my questions. It is only because I'm unable to find the answers.

Thank you so much,
Richard

------------------------------
Richard Jansky
Head of RA / RM / QM
Beringen
Switzerland
------------------------------

Thank you very much for your time, Erik! I'm afraid I pulled you on the wrong track by providing too little information.

To illustrate my issue:
I develop a little computer, which can handle a sensor that I also develop.

In my opinion, only the entire system has a medical purpose, since neither the computer nor the sensor by themselves can do much.

In order for me to place the system on the market, I can declare the system to be a medical device.

Or, as I see other manufacturers do, I select the computer to be my medical device with the sensor intended to be used together with it to enable its intended purpose (i.e. the sensor being an accessory). They then place the computer and the sensor with their own Declarations of Conformity (DoC) on the market. Then, they extend the DoC of the sensor with other substantially equivalent sensors.

Now my questions are in case I want to have 2 DoCs (computer, sensor):
- is there a guideline that helps me decide if the computer or the sensor should be my "medical device"?
- as the MDR also applies to accessories, how do I handle clinical aspects for such as 14971 or 14155 in the Technical Documentation of the sensor? To me the sensor (accessory) doesn't have a medical purpose other than enabling the medical purpose of the medical device (computer).
- it seems the advantage of having a separate DoC just for the accesory is the ability to extend it with a list with substantially equivalent devices. Or, considering the different life cycles of the computer and the sensors, I would not need to provide a full set of new Technical Documentation when I upgrade one of them. Is this correct?

Again, thank you very much for your patience,
Richard

------------------------------
Richard Jansky
Head of RA / RM / QM
Beringen
Switzerland
------------------------------

Original Message:
Sent: 04-Feb-2022 03:03
From: Erik Vollebregt
Subject: Handling a System of Accessories

Several remarks that may help to untangle this knot for you:

• Accessories are not classified as medical devices but as 'devices', the overarching concept of 'regulated subject matter' under the MDR, covering medical devices, accessories and Annex XVI devices ('non-medical devices').
• A medical device that 'needs' another device is not an accessory as you seem to state, but may also be a compatible or interoperable medical device (see Annex I, point 14.5). Rather with accessory qualification it is the other way around from how you seem to approach it: the device that acts as an accessory to a medical device is the accessory (see the definition in the MDR), not a device that 'needs' another device or product.
• There is nothing in the text of article 22 (1) MDR to prevent you from assembling a system of accessories, because the text does not require that there is a 'main medical device' around which the system revolves or something ("combine devices bearing a CE marking with the following other devices or products, in a manner that is compatible with the intended purpose of the devices or other products and within the limits of use specified by their manufacturers, in order to place them on the market as a system")(underlining added)

Maybe rethink with this in mind and see if that changes your conclusion. And otherwise, maybe provide more information about the actual products - allows for better feedback.

Good luck!

------------------------------
Erik Vollebregt
Partner
Amsterdam
Netherlands

Original Message:
Sent: 03-Feb-2022 07:05
From: Richard Jansky
Subject: Handling a System of Accessories

Dear All

In the past I placed medical devices on the EU market. However, now I'm confronted with systems of accessories. So hence, my questions (3).

If I develop a system that has a medical purpose and consists of products, of which none can be claimed by itself to be a medical device as it needs the others (see MDR Art 2 (1, 2)), based on what do I select the one that is the "medical device" and, therefore, the other ones to be its accessories? Do I simply choose the "brain", which coordinates the usage, or do I pick any other "important" product?

Once I decided on the accessories and develop them with their own Declaration of Conformity (DoC), how do I handle the clinical side of the technical documentation (risk management, clinical evalation)? By the MDR concept, accessories have no medical purpose, but are classified as medical devices. Do I stick with the wording of the MDR and say their medical purpose is to enable the medical device?

And thirdly, as I know companies with DoCs containing only accessories, what are the pros & cons of separating their DoCs from those of the medical devices that use them?

I apologize for the density of my questions. It is only because I'm unable to find the answers.

Thank you so much,
Richard

------------------------------
Richard Jansky
Head of RA / RM / QM
Beringen
Switzerland
------------------------------

Hi Richard, more questions for you: 

"a little computer, which can handle a sensor that I also develop"

Let start with the basics again before we go into the complex stuff that flows from that.

- "little computer" - computers alone are not much use. Is the computer a medical device in the first place, or only the software running on it? If the computer is off the shelf hardware while the magic happens in the software the computer does not need to be a medical device. And what does the software do? Does it just display sensor data or does it perform its own action on the sensor data, e.g. to trend measurements and score measurements relative to user settings?
 - "handle a sensor" - in what way? Does the computer need the sensor (e.g. to make the software provide clinical decision support to the user) or does the sensor need the computer (e.g. because it is a self contained system that uses the computer as display for results)? These two examples lead to two different device-accessory relationships. 

Again, medical device and accesory are defined terms in the MDR, so they apply based on the factual situation. That means that you cannot 'select' something to be a medical device or accessory, you define an intended purpose and the purpose determines if the product is a medical devices or an accessory. I cannot 'select' a brick to be a medical device, but I can assign it an intended purpose as 'to be used for rapid anestesia' for example.

Your questions go all the way back to the oldest of MEDDEV document 2.1/1 from 1994 (!) which describes the difference between a medical device and an accessory. Note that the definition of accessory has become a lot broader under the MDR (includes not only to 'enable' but also to 'assist' , and if you have software in the mix, check out MDCG 2019-11 on software accessories.

So let start with with what your computer and sensor are intended to do, because that determines what they are for MDR purposes.

------------------------------
Erik Vollebregt
Partner
Amsterdam
Netherlands
------------------------------

Original Message:
Sent: 04-Feb-2022 05:50
From: Richard Jansky
Subject: Handling a System of Accessories

Thank you very much for your time, Erik! I'm afraid I pulled you on the wrong track by providing too little information.

To illustrate my issue:
I develop a little computer, which can handle a sensor that I also develop.

In my opinion, only the entire system has a medical purpose, since neither the computer nor the sensor by themselves can do much.

In order for me to place the system on the market, I can declare the system to be a medical device.

Or, as I see other manufacturers do, I select the computer to be my medical device with the sensor intended to be used together with it to enable its intended purpose (i.e. the sensor being an accessory). They then place the computer and the sensor with their own Declarations of Conformity (DoC) on the market. Then, they extend the DoC of the sensor with other substantially equivalent sensors.

Now my questions are in case I want to have 2 DoCs (computer, sensor):
- is there a guideline that helps me decide if the computer or the sensor should be my "medical device"?
- as the MDR also applies to accessories, how do I handle clinical aspects for such as 14971 or 14155 in the Technical Documentation of the sensor? To me the sensor (accessory) doesn't have a medical purpose other than enabling the medical purpose of the medical device (computer).
- it seems the advantage of having a separate DoC just for the accesory is the ability to extend it with a list with substantially equivalent devices. Or, considering the different life cycles of the computer and the sensors, I would not need to provide a full set of new Technical Documentation when I upgrade one of them. Is this correct?

Again, thank you very much for your patience,
Richard

------------------------------
Richard Jansky
Head of RA / RM / QM
Beringen
Switzerland

Original Message:
Sent: 04-Feb-2022 03:03
From: Erik Vollebregt
Subject: Handling a System of Accessories

Several remarks that may help to untangle this knot for you:

• Accessories are not classified as medical devices but as 'devices', the overarching concept of 'regulated subject matter' under the MDR, covering medical devices, accessories and Annex XVI devices ('non-medical devices').
• A medical device that 'needs' another device is not an accessory as you seem to state, but may also be a compatible or interoperable medical device (see Annex I, point 14.5). Rather with accessory qualification it is the other way around from how you seem to approach it: the device that acts as an accessory to a medical device is the accessory (see the definition in the MDR), not a device that 'needs' another device or product.
• There is nothing in the text of article 22 (1) MDR to prevent you from assembling a system of accessories, because the text does not require that there is a 'main medical device' around which the system revolves or something ("combine devices bearing a CE marking with the following other devices or products, in a manner that is compatible with the intended purpose of the devices or other products and within the limits of use specified by their manufacturers, in order to place them on the market as a system")(underlining added)

Maybe rethink with this in mind and see if that changes your conclusion. And otherwise, maybe provide more information about the actual products - allows for better feedback.

Good luck!

------------------------------
Erik Vollebregt
Partner
Amsterdam
Netherlands

Original Message:
Sent: 03-Feb-2022 07:05
From: Richard Jansky
Subject: Handling a System of Accessories

Dear All

In the past I placed medical devices on the EU market. However, now I'm confronted with systems of accessories. So hence, my questions (3).

If I develop a system that has a medical purpose and consists of products, of which none can be claimed by itself to be a medical device as it needs the others (see MDR Art 2 (1, 2)), based on what do I select the one that is the "medical device" and, therefore, the other ones to be its accessories? Do I simply choose the "brain", which coordinates the usage, or do I pick any other "important" product?

Once I decided on the accessories and develop them with their own Declaration of Conformity (DoC), how do I handle the clinical side of the technical documentation (risk management, clinical evalation)? By the MDR concept, accessories have no medical purpose, but are classified as medical devices. Do I stick with the wording of the MDR and say their medical purpose is to enable the medical device?

And thirdly, as I know companies with DoCs containing only accessories, what are the pros & cons of separating their DoCs from those of the medical devices that use them?

I apologize for the density of my questions. It is only because I'm unable to find the answers.

Thank you so much,
Richard

------------------------------
Richard Jansky
Head of RA / RM / QM
Beringen
Switzerland
------------------------------

Hi Eric
Sorry, it took me a little to robustly analyze the situation.

My "computer" is a self-developed box with a display to which a sensor / probe is connected
- to display the sensor data e.g. the current temperature
- to store that data
- to preconfigure the sensor for a certain accuracy.
So the "computer" isn't off-the-shelf.

The sensor is self-developed and has no SW and, therefore, passes data to the "computer" and is energy-fed by it.

Thus, the "computer" needs the sensor, but the sensor needs also the "computer" as it uses proprietary protocols to pass its data to the "computer". So to me, only the system of both parts can be a medical device as it can satisfy the medical purpose only as a system. Thus, I still tend to "choose" the computer to be my medical device, but my arguments are thin.

I hope this is understandable.

Thank you so much,
Richard

------------------------------
Richard Jansky
Head of RA / RM / QM
Beringen
Switzerland
------------------------------

Original Message:
Sent: 05-Feb-2022 03:11
From: Erik Vollebregt
Subject: Handling a System of Accessories

Hi Richard, more questions for you:

"a little computer, which can handle a sensor that I also develop"

Let start with the basics again before we go into the complex stuff that flows from that.

- "little computer" - computers alone are not much use. Is the computer a medical device in the first place, or only the software running on it? If the computer is off the shelf hardware while the magic happens in the software the computer does not need to be a medical device. And what does the software do? Does it just display sensor data or does it perform its own action on the sensor data, e.g. to trend measurements and score measurements relative to user settings?
 - "handle a sensor" - in what way? Does the computer need the sensor (e.g. to make the software provide clinical decision support to the user) or does the sensor need the computer (e.g. because it is a self contained system that uses the computer as display for results)? These two examples lead to two different device-accessory relationships.

Again, medical device and accesory are defined terms in the MDR, so they apply based on the factual situation. That means that you cannot 'select' something to be a medical device or accessory, you define an intended purpose and the purpose determines if the product is a medical devices or an accessory. I cannot 'select' a brick to be a medical device, but I can assign it an intended purpose as 'to be used for rapid anestesia' for example.

Your questions go all the way back to the oldest of MEDDEV document 2.1/1 from 1994 (!) which describes the difference between a medical device and an accessory. Note that the definition of accessory has become a lot broader under the MDR (includes not only to 'enable' but also to 'assist' , and if you have software in the mix, check out MDCG 2019-11 on software accessories.

So let start with with what your computer and sensor are intended to do, because that determines what they are for MDR purposes.

------------------------------
Erik Vollebregt
Partner
Amsterdam
Netherlands

Original Message:
Sent: 04-Feb-2022 05:50
From: Richard Jansky
Subject: Handling a System of Accessories

Thank you very much for your time, Erik! I'm afraid I pulled you on the wrong track by providing too little information.

To illustrate my issue:
I develop a little computer, which can handle a sensor that I also develop.

In my opinion, only the entire system has a medical purpose, since neither the computer nor the sensor by themselves can do much.

In order for me to place the system on the market, I can declare the system to be a medical device.

Or, as I see other manufacturers do, I select the computer to be my medical device with the sensor intended to be used together with it to enable its intended purpose (i.e. the sensor being an accessory). They then place the computer and the sensor with their own Declarations of Conformity (DoC) on the market. Then, they extend the DoC of the sensor with other substantially equivalent sensors.

Now my questions are in case I want to have 2 DoCs (computer, sensor):
- is there a guideline that helps me decide if the computer or the sensor should be my "medical device"?
- as the MDR also applies to accessories, how do I handle clinical aspects for such as 14971 or 14155 in the Technical Documentation of the sensor? To me the sensor (accessory) doesn't have a medical purpose other than enabling the medical purpose of the medical device (computer).
- it seems the advantage of having a separate DoC just for the accesory is the ability to extend it with a list with substantially equivalent devices. Or, considering the different life cycles of the computer and the sensors, I would not need to provide a full set of new Technical Documentation when I upgrade one of them. Is this correct?

Again, thank you very much for your patience,
Richard

------------------------------
Richard Jansky
Head of RA / RM / QM
Beringen
Switzerland

Original Message:
Sent: 04-Feb-2022 03:03
From: Erik Vollebregt
Subject: Handling a System of Accessories

Several remarks that may help to untangle this knot for you:

• Accessories are not classified as medical devices but as 'devices', the overarching concept of 'regulated subject matter' under the MDR, covering medical devices, accessories and Annex XVI devices ('non-medical devices').
• A medical device that 'needs' another device is not an accessory as you seem to state, but may also be a compatible or interoperable medical device (see Annex I, point 14.5). Rather with accessory qualification it is the other way around from how you seem to approach it: the device that acts as an accessory to a medical device is the accessory (see the definition in the MDR), not a device that 'needs' another device or product.
• There is nothing in the text of article 22 (1) MDR to prevent you from assembling a system of accessories, because the text does not require that there is a 'main medical device' around which the system revolves or something ("combine devices bearing a CE marking with the following other devices or products, in a manner that is compatible with the intended purpose of the devices or other products and within the limits of use specified by their manufacturers, in order to place them on the market as a system")(underlining added)

Maybe rethink with this in mind and see if that changes your conclusion. And otherwise, maybe provide more information about the actual products - allows for better feedback.

Good luck!

------------------------------
Erik Vollebregt
Partner
Amsterdam
Netherlands

Original Message:
Sent: 03-Feb-2022 07:05
From: Richard Jansky
Subject: Handling a System of Accessories

Dear All

In the past I placed medical devices on the EU market. However, now I'm confronted with systems of accessories. So hence, my questions (3).

If I develop a system that has a medical purpose and consists of products, of which none can be claimed by itself to be a medical device as it needs the others (see MDR Art 2 (1, 2)), based on what do I select the one that is the "medical device" and, therefore, the other ones to be its accessories? Do I simply choose the "brain", which coordinates the usage, or do I pick any other "important" product?

Once I decided on the accessories and develop them with their own Declaration of Conformity (DoC), how do I handle the clinical side of the technical documentation (risk management, clinical evalation)? By the MDR concept, accessories have no medical purpose, but are classified as medical devices. Do I stick with the wording of the MDR and say their medical purpose is to enable the medical device?

And thirdly, as I know companies with DoCs containing only accessories, what are the pros & cons of separating their DoCs from those of the medical devices that use them?

I apologize for the density of my questions. It is only because I'm unable to find the answers.

Thank you so much,
Richard

------------------------------
Richard Jansky
Head of RA / RM / QM
Beringen
Switzerland
------------------------------

Hi Erik,

Recent discussions have seriously confused me on this topic.

Where in regulations is a device distinguished from a medical device? I was also surprised to hear that devices with no medical purpose are not medical devices. I assumed that "devices with no medical purpose" is the same as "medical devices with no medical purpose."

I would like to have a better understanding of this subject...

Thanks so much for weighing in on this important topic.

------------------------------
Corey Jaseph RAC
Senior Research Analyst
Wheatland CA
United States
------------------------------

Original Message:
Sent: 04-Feb-2022 03:03
From: Erik Vollebregt
Subject: Handling a System of Accessories

Several remarks that may help to untangle this knot for you:

• Accessories are not classified as medical devices but as 'devices', the overarching concept of 'regulated subject matter' under the MDR, covering medical devices, accessories and Annex XVI devices ('non-medical devices').
• A medical device that 'needs' another device is not an accessory as you seem to state, but may also be a compatible or interoperable medical device (see Annex I, point 14.5). Rather with accessory qualification it is the other way around from how you seem to approach it: the device that acts as an accessory to a medical device is the accessory (see the definition in the MDR), not a device that 'needs' another device or product.
• There is nothing in the text of article 22 (1) MDR to prevent you from assembling a system of accessories, because the text does not require that there is a 'main medical device' around which the system revolves or something ("combine devices bearing a CE marking with the following other devices or products, in a manner that is compatible with the intended purpose of the devices or other products and within the limits of use specified by their manufacturers, in order to place them on the market as a system")(underlining added)

Maybe rethink with this in mind and see if that changes your conclusion. And otherwise, maybe provide more information about the actual products - allows for better feedback.

Good luck!

------------------------------
Erik Vollebregt
Partner
Amsterdam
Netherlands

Original Message:
Sent: 03-Feb-2022 07:05
From: Richard Jansky
Subject: Handling a System of Accessories

Dear All

In the past I placed medical devices on the EU market. However, now I'm confronted with systems of accessories. So hence, my questions (3).

If I develop a system that has a medical purpose and consists of products, of which none can be claimed by itself to be a medical device as it needs the others (see MDR Art 2 (1, 2)), based on what do I select the one that is the "medical device" and, therefore, the other ones to be its accessories? Do I simply choose the "brain", which coordinates the usage, or do I pick any other "important" product?

Once I decided on the accessories and develop them with their own Declaration of Conformity (DoC), how do I handle the clinical side of the technical documentation (risk management, clinical evalation)? By the MDR concept, accessories have no medical purpose, but are classified as medical devices. Do I stick with the wording of the MDR and say their medical purpose is to enable the medical device?

And thirdly, as I know companies with DoCs containing only accessories, what are the pros & cons of separating their DoCs from those of the medical devices that use them?

I apologize for the density of my questions. It is only because I'm unable to find the answers.

Thank you so much,
Richard

------------------------------
Richard Jansky
Head of RA / RM / QM
Beringen
Switzerland
------------------------------

Hi Corey, see article 1 (4) of the MDR: "For the purposes of this Regulation, medical devices, accessories for medical devices, and products listed in Annex XVI to which this Regulation applies pursuant to paragraph 2 shall hereinafter be referred to as 'devices'."

Medical devices and accessories are differently defined terms, see article 2 (1) MDR for medical device and 2 (2) for accessory. 

Medical device without medical purpose would not be possible under the MDR, because then the element "intended by the manufacturer to be used [...] for one of more of the following specific medical purposes" in article 2 (1) MDR would not be met. See also article 2 (12) which defines the intended purpose: if the manufacturer does not intended the device to be used medically then the device is not a medical device.

This has been clarified by the European Court in the Brain Products case in relation to two versions of the same product (an apparatus for recording brain activity), of which one had a medical intended use, and the other not. So the first is a medical device, and the other a general product - see https://eur-lex.europa.eu/legal-content/en/TXT/?uri=CELEX:62011CJ0219

------------------------------
Erik Vollebregt
Partner
Amsterdam
Netherlands
------------------------------

Original Message:
Sent: 04-Feb-2022 11:50
From: Corey Jaseph
Subject: Handling a System of Accessories

Hi Erik,

Recent discussions have seriously confused me on this topic.

Where in regulations is a device distinguished from a medical device? I was also surprised to hear that devices with no medical purpose are not medical devices. I assumed that "devices with no medical purpose" is the same as "medical devices with no medical purpose."

I would like to have a better understanding of this subject...

Thanks so much for weighing in on this important topic.

------------------------------
Corey Jaseph RAC
Senior Research Analyst
Wheatland CA
United States

Original Message:
Sent: 04-Feb-2022 03:03
From: Erik Vollebregt
Subject: Handling a System of Accessories

Several remarks that may help to untangle this knot for you:

• Accessories are not classified as medical devices but as 'devices', the overarching concept of 'regulated subject matter' under the MDR, covering medical devices, accessories and Annex XVI devices ('non-medical devices').
• A medical device that 'needs' another device is not an accessory as you seem to state, but may also be a compatible or interoperable medical device (see Annex I, point 14.5). Rather with accessory qualification it is the other way around from how you seem to approach it: the device that acts as an accessory to a medical device is the accessory (see the definition in the MDR), not a device that 'needs' another device or product.
• There is nothing in the text of article 22 (1) MDR to prevent you from assembling a system of accessories, because the text does not require that there is a 'main medical device' around which the system revolves or something ("combine devices bearing a CE marking with the following other devices or products, in a manner that is compatible with the intended purpose of the devices or other products and within the limits of use specified by their manufacturers, in order to place them on the market as a system")(underlining added)

Maybe rethink with this in mind and see if that changes your conclusion. And otherwise, maybe provide more information about the actual products - allows for better feedback.

Good luck!

------------------------------
Erik Vollebregt
Partner
Amsterdam
Netherlands

Original Message:
Sent: 03-Feb-2022 07:05
From: Richard Jansky
Subject: Handling a System of Accessories

Dear All

In the past I placed medical devices on the EU market. However, now I'm confronted with systems of accessories. So hence, my questions (3).

If I develop a system that has a medical purpose and consists of products, of which none can be claimed by itself to be a medical device as it needs the others (see MDR Art 2 (1, 2)), based on what do I select the one that is the "medical device" and, therefore, the other ones to be its accessories? Do I simply choose the "brain", which coordinates the usage, or do I pick any other "important" product?

Once I decided on the accessories and develop them with their own Declaration of Conformity (DoC), how do I handle the clinical side of the technical documentation (risk management, clinical evalation)? By the MDR concept, accessories have no medical purpose, but are classified as medical devices. Do I stick with the wording of the MDR and say their medical purpose is to enable the medical device?

And thirdly, as I know companies with DoCs containing only accessories, what are the pros & cons of separating their DoCs from those of the medical devices that use them?

I apologize for the density of my questions. It is only because I'm unable to find the answers.

Thank you so much,
Richard

------------------------------
Richard Jansky
Head of RA / RM / QM
Beringen
Switzerland
------------------------------

Hi Richard J

Back to the question about why to have separate DoCs... One good reason could be if the devices have different risk classes, different Basic UDI-DIs, and different EMDN codes.

If a class I device and a class III device are meant to be used together, you may have one clinical evaluation file that applies to both, included by reference in both technical documentation files. But your class III device will have a lot of its own technical documentation that you won't need to produce for the class I device.

------------------------------
Anne LeBlanc
United States
------------------------------

Original Message:
Sent: 04-Feb-2022 12:14
From: Erik Vollebregt
Subject: Handling a System of Accessories

Hi Corey, see article 1 (4) of the MDR: "For the purposes of this Regulation, medical devices, accessories for medical devices, and products listed in Annex XVI to which this Regulation applies pursuant to paragraph 2 shall hereinafter be referred to as 'devices'."

Medical devices and accessories are differently defined terms, see article 2 (1) MDR for medical device and 2 (2) for accessory.

Medical device without medical purpose would not be possible under the MDR, because then the element "intended by the manufacturer to be used [...] for one of more of the following specific medical purposes" in article 2 (1) MDR would not be met. See also article 2 (12) which defines the intended purpose: if the manufacturer does not intended the device to be used medically then the device is not a medical device.

This has been clarified by the European Court in the Brain Products case in relation to two versions of the same product (an apparatus for recording brain activity), of which one had a medical intended use, and the other not. So the first is a medical device, and the other a general product - see https://eur-lex.europa.eu/legal-content/en/TXT/?uri=CELEX:62011CJ0219

------------------------------
Erik Vollebregt
Partner
Amsterdam
Netherlands

Original Message:
Sent: 04-Feb-2022 11:50
From: Corey Jaseph
Subject: Handling a System of Accessories

Hi Erik,

Recent discussions have seriously confused me on this topic.

Where in regulations is a device distinguished from a medical device? I was also surprised to hear that devices with no medical purpose are not medical devices. I assumed that "devices with no medical purpose" is the same as "medical devices with no medical purpose."

I would like to have a better understanding of this subject...

Thanks so much for weighing in on this important topic.

------------------------------
Corey Jaseph RAC
Senior Research Analyst
Wheatland CA
United States

Original Message:
Sent: 04-Feb-2022 03:03
From: Erik Vollebregt
Subject: Handling a System of Accessories

Several remarks that may help to untangle this knot for you:

• Accessories are not classified as medical devices but as 'devices', the overarching concept of 'regulated subject matter' under the MDR, covering medical devices, accessories and Annex XVI devices ('non-medical devices').
• A medical device that 'needs' another device is not an accessory as you seem to state, but may also be a compatible or interoperable medical device (see Annex I, point 14.5). Rather with accessory qualification it is the other way around from how you seem to approach it: the device that acts as an accessory to a medical device is the accessory (see the definition in the MDR), not a device that 'needs' another device or product.
• There is nothing in the text of article 22 (1) MDR to prevent you from assembling a system of accessories, because the text does not require that there is a 'main medical device' around which the system revolves or something ("combine devices bearing a CE marking with the following other devices or products, in a manner that is compatible with the intended purpose of the devices or other products and within the limits of use specified by their manufacturers, in order to place them on the market as a system")(underlining added)

Maybe rethink with this in mind and see if that changes your conclusion. And otherwise, maybe provide more information about the actual products - allows for better feedback.

Good luck!

------------------------------
Erik Vollebregt
Partner
Amsterdam
Netherlands

Original Message:
Sent: 03-Feb-2022 07:05
From: Richard Jansky
Subject: Handling a System of Accessories

Dear All

In the past I placed medical devices on the EU market. However, now I'm confronted with systems of accessories. So hence, my questions (3).

If I develop a system that has a medical purpose and consists of products, of which none can be claimed by itself to be a medical device as it needs the others (see MDR Art 2 (1, 2)), based on what do I select the one that is the "medical device" and, therefore, the other ones to be its accessories? Do I simply choose the "brain", which coordinates the usage, or do I pick any other "important" product?

Once I decided on the accessories and develop them with their own Declaration of Conformity (DoC), how do I handle the clinical side of the technical documentation (risk management, clinical evalation)? By the MDR concept, accessories have no medical purpose, but are classified as medical devices. Do I stick with the wording of the MDR and say their medical purpose is to enable the medical device?

And thirdly, as I know companies with DoCs containing only accessories, what are the pros & cons of separating their DoCs from those of the medical devices that use them?

I apologize for the density of my questions. It is only because I'm unable to find the answers.

Thank you so much,
Richard

------------------------------
Richard Jansky
Head of RA / RM / QM
Beringen
Switzerland
------------------------------

Hi Anne

That makes sense. I can also see that you want to upgrade one device using a different life cycle than the other, which ultimately also goes into your topic.

Thank you for your feedback,
Richard

------------------------------
Richard Jansky
Head of RA / RM / QM
Beringen
Switzerland
------------------------------

Original Message:
Sent: 05-Feb-2022 09:51
From: Anne LeBlanc
Subject: Handling a System of Accessories

Hi Richard J

Back to the question about why to have separate DoCs... One good reason could be if the devices have different risk classes, different Basic UDI-DIs, and different EMDN codes.

If a class I device and a class III device are meant to be used together, you may have one clinical evaluation file that applies to both, included by reference in both technical documentation files. But your class III device will have a lot of its own technical documentation that you won't need to produce for the class I device.

------------------------------
Anne LeBlanc
United States

Original Message:
Sent: 04-Feb-2022 12:14
From: Erik Vollebregt
Subject: Handling a System of Accessories

Hi Corey, see article 1 (4) of the MDR: "For the purposes of this Regulation, medical devices, accessories for medical devices, and products listed in Annex XVI to which this Regulation applies pursuant to paragraph 2 shall hereinafter be referred to as 'devices'."

Medical devices and accessories are differently defined terms, see article 2 (1) MDR for medical device and 2 (2) for accessory.

Medical device without medical purpose would not be possible under the MDR, because then the element "intended by the manufacturer to be used [...] for one of more of the following specific medical purposes" in article 2 (1) MDR would not be met. See also article 2 (12) which defines the intended purpose: if the manufacturer does not intended the device to be used medically then the device is not a medical device.

This has been clarified by the European Court in the Brain Products case in relation to two versions of the same product (an apparatus for recording brain activity), of which one had a medical intended use, and the other not. So the first is a medical device, and the other a general product - see https://eur-lex.europa.eu/legal-content/en/TXT/?uri=CELEX:62011CJ0219

------------------------------
Erik Vollebregt
Partner
Amsterdam
Netherlands

Original Message:
Sent: 04-Feb-2022 11:50
From: Corey Jaseph
Subject: Handling a System of Accessories

Hi Erik,

Recent discussions have seriously confused me on this topic.

Where in regulations is a device distinguished from a medical device? I was also surprised to hear that devices with no medical purpose are not medical devices. I assumed that "devices with no medical purpose" is the same as "medical devices with no medical purpose."

I would like to have a better understanding of this subject...

Thanks so much for weighing in on this important topic.

------------------------------
Corey Jaseph RAC
Senior Research Analyst
Wheatland CA
United States

Original Message:
Sent: 04-Feb-2022 03:03
From: Erik Vollebregt
Subject: Handling a System of Accessories

Several remarks that may help to untangle this knot for you:

• Accessories are not classified as medical devices but as 'devices', the overarching concept of 'regulated subject matter' under the MDR, covering medical devices, accessories and Annex XVI devices ('non-medical devices').
• A medical device that 'needs' another device is not an accessory as you seem to state, but may also be a compatible or interoperable medical device (see Annex I, point 14.5). Rather with accessory qualification it is the other way around from how you seem to approach it: the device that acts as an accessory to a medical device is the accessory (see the definition in the MDR), not a device that 'needs' another device or product.
• There is nothing in the text of article 22 (1) MDR to prevent you from assembling a system of accessories, because the text does not require that there is a 'main medical device' around which the system revolves or something ("combine devices bearing a CE marking with the following other devices or products, in a manner that is compatible with the intended purpose of the devices or other products and within the limits of use specified by their manufacturers, in order to place them on the market as a system")(underlining added)

Maybe rethink with this in mind and see if that changes your conclusion. And otherwise, maybe provide more information about the actual products - allows for better feedback.

Good luck!

------------------------------
Erik Vollebregt
Partner
Amsterdam
Netherlands

Original Message:
Sent: 03-Feb-2022 07:05
From: Richard Jansky
Subject: Handling a System of Accessories

Dear All

In the past I placed medical devices on the EU market. However, now I'm confronted with systems of accessories. So hence, my questions (3).

If I develop a system that has a medical purpose and consists of products, of which none can be claimed by itself to be a medical device as it needs the others (see MDR Art 2 (1, 2)), based on what do I select the one that is the "medical device" and, therefore, the other ones to be its accessories? Do I simply choose the "brain", which coordinates the usage, or do I pick any other "important" product?

Once I decided on the accessories and develop them with their own Declaration of Conformity (DoC), how do I handle the clinical side of the technical documentation (risk management, clinical evalation)? By the MDR concept, accessories have no medical purpose, but are classified as medical devices. Do I stick with the wording of the MDR and say their medical purpose is to enable the medical device?

And thirdly, as I know companies with DoCs containing only accessories, what are the pros & cons of separating their DoCs from those of the medical devices that use them?

I apologize for the density of my questions. It is only because I'm unable to find the answers.

Thank you so much,
Richard

------------------------------
Richard Jansky
Head of RA / RM / QM
Beringen
Switzerland
------------------------------

This message was posted by a user wishing to remain anonymous

Hi RAPS colleagues,

If we combine the accessories (optional) with the main system in the same technical file, is it required that the accessories need be compliant to MDR requirements like having MD symbol, UDI symbols as these accessories are not basically medical devices in itself and doesn't have its own medical intended use.

The expectation from NB is that if we declare some components as accessories then they should be having MD, UDI symbols and other information as per MDR.

Original Message:
Sent: 04-Feb-2022 12:14
From: Erik Vollebregt
Subject: Handling a System of Accessories

Hi Corey, see article 1 (4) of the MDR: "For the purposes of this Regulation, medical devices, accessories for medical devices, and products listed in Annex XVI to which this Regulation applies pursuant to paragraph 2 shall hereinafter be referred to as 'devices'."

Medical devices and accessories are differently defined terms, see article 2 (1) MDR for medical device and 2 (2) for accessory.

Medical device without medical purpose would not be possible under the MDR, because then the element "intended by the manufacturer to be used [...] for one of more of the following specific medical purposes" in article 2 (1) MDR would not be met. See also article 2 (12) which defines the intended purpose: if the manufacturer does not intended the device to be used medically then the device is not a medical device.

This has been clarified by the European Court in the Brain Products case in relation to two versions of the same product (an apparatus for recording brain activity), of which one had a medical intended use, and the other not. So the first is a medical device, and the other a general product - see https://eur-lex.europa.eu/legal-content/en/TXT/?uri=CELEX:62011CJ0219

------------------------------
Erik Vollebregt
Partner
Amsterdam
Netherlands

Original Message:
Sent: 04-Feb-2022 11:50
From: Corey Jaseph
Subject: Handling a System of Accessories

Hi Erik,

Recent discussions have seriously confused me on this topic.

Where in regulations is a device distinguished from a medical device? I was also surprised to hear that devices with no medical purpose are not medical devices. I assumed that "devices with no medical purpose" is the same as "medical devices with no medical purpose."

I would like to have a better understanding of this subject...

Thanks so much for weighing in on this important topic.

------------------------------
Corey Jaseph RAC
Senior Research Analyst
Wheatland CA
United States

Original Message:
Sent: 04-Feb-2022 03:03
From: Erik Vollebregt
Subject: Handling a System of Accessories

Several remarks that may help to untangle this knot for you:

• Accessories are not classified as medical devices but as 'devices', the overarching concept of 'regulated subject matter' under the MDR, covering medical devices, accessories and Annex XVI devices ('non-medical devices').
• A medical device that 'needs' another device is not an accessory as you seem to state, but may also be a compatible or interoperable medical device (see Annex I, point 14.5). Rather with accessory qualification it is the other way around from how you seem to approach it: the device that acts as an accessory to a medical device is the accessory (see the definition in the MDR), not a device that 'needs' another device or product.
• There is nothing in the text of article 22 (1) MDR to prevent you from assembling a system of accessories, because the text does not require that there is a 'main medical device' around which the system revolves or something ("combine devices bearing a CE marking with the following other devices or products, in a manner that is compatible with the intended purpose of the devices or other products and within the limits of use specified by their manufacturers, in order to place them on the market as a system")(underlining added)

Maybe rethink with this in mind and see if that changes your conclusion. And otherwise, maybe provide more information about the actual products - allows for better feedback.

Good luck!

------------------------------
Erik Vollebregt
Partner
Amsterdam
Netherlands

Original Message:
Sent: 03-Feb-2022 07:05
From: Richard Jansky
Subject: Handling a System of Accessories

Dear All

In the past I placed medical devices on the EU market. However, now I'm confronted with systems of accessories. So hence, my questions (3).

If I develop a system that has a medical purpose and consists of products, of which none can be claimed by itself to be a medical device as it needs the others (see MDR Art 2 (1, 2)), based on what do I select the one that is the "medical device" and, therefore, the other ones to be its accessories? Do I simply choose the "brain", which coordinates the usage, or do I pick any other "important" product?

Once I decided on the accessories and develop them with their own Declaration of Conformity (DoC), how do I handle the clinical side of the technical documentation (risk management, clinical evalation)? By the MDR concept, accessories have no medical purpose, but are classified as medical devices. Do I stick with the wording of the MDR and say their medical purpose is to enable the medical device?

And thirdly, as I know companies with DoCs containing only accessories, what are the pros & cons of separating their DoCs from those of the medical devices that use them?

I apologize for the density of my questions. It is only because I'm unable to find the answers.

Thank you so much,
Richard

------------------------------
Richard Jansky
Head of RA / RM / QM
Beringen
Switzerland
------------------------------

Hi Anon

Check carefully the definition of accessory. If your optional components meet the definition of accessory, then they are devices under the MDR and the device labeling rules are applicable.

------------------------------
Anne LeBlanc
United States
------------------------------

Original Message:
Sent: 07-Feb-2022 03:54
From: Anonymous Member
Subject: Handling a System of Accessories

This message was posted by a user wishing to remain anonymous

Hi RAPS colleagues,

If we combine the accessories (optional) with the main system in the same technical file, is it required that the accessories need be compliant to MDR requirements like having MD symbol, UDI symbols as these accessories are not basically medical devices in itself and doesn't have its own medical intended use.

The expectation from NB is that if we declare some components as accessories then they should be having MD, UDI symbols and other information as per MDR.

Original Message:
Sent: 04-Feb-2022 12:14
From: Erik Vollebregt
Subject: Handling a System of Accessories

Hi Corey, see article 1 (4) of the MDR: "For the purposes of this Regulation, medical devices, accessories for medical devices, and products listed in Annex XVI to which this Regulation applies pursuant to paragraph 2 shall hereinafter be referred to as 'devices'."

Medical devices and accessories are differently defined terms, see article 2 (1) MDR for medical device and 2 (2) for accessory.

Medical device without medical purpose would not be possible under the MDR, because then the element "intended by the manufacturer to be used [...] for one of more of the following specific medical purposes" in article 2 (1) MDR would not be met. See also article 2 (12) which defines the intended purpose: if the manufacturer does not intended the device to be used medically then the device is not a medical device.

This has been clarified by the European Court in the Brain Products case in relation to two versions of the same product (an apparatus for recording brain activity), of which one had a medical intended use, and the other not. So the first is a medical device, and the other a general product - see https://eur-lex.europa.eu/legal-content/en/TXT/?uri=CELEX:62011CJ0219

------------------------------
Erik Vollebregt
Partner
Amsterdam
Netherlands

Original Message:
Sent: 04-Feb-2022 11:50
From: Corey Jaseph
Subject: Handling a System of Accessories

Hi Erik,

Recent discussions have seriously confused me on this topic.

Where in regulations is a device distinguished from a medical device? I was also surprised to hear that devices with no medical purpose are not medical devices. I assumed that "devices with no medical purpose" is the same as "medical devices with no medical purpose."

I would like to have a better understanding of this subject...

Thanks so much for weighing in on this important topic.

------------------------------
Corey Jaseph RAC
Senior Research Analyst
Wheatland CA
United States

Original Message:
Sent: 04-Feb-2022 03:03
From: Erik Vollebregt
Subject: Handling a System of Accessories

Several remarks that may help to untangle this knot for you:

• Accessories are not classified as medical devices but as 'devices', the overarching concept of 'regulated subject matter' under the MDR, covering medical devices, accessories and Annex XVI devices ('non-medical devices').
• A medical device that 'needs' another device is not an accessory as you seem to state, but may also be a compatible or interoperable medical device (see Annex I, point 14.5). Rather with accessory qualification it is the other way around from how you seem to approach it: the device that acts as an accessory to a medical device is the accessory (see the definition in the MDR), not a device that 'needs' another device or product.
• There is nothing in the text of article 22 (1) MDR to prevent you from assembling a system of accessories, because the text does not require that there is a 'main medical device' around which the system revolves or something ("combine devices bearing a CE marking with the following other devices or products, in a manner that is compatible with the intended purpose of the devices or other products and within the limits of use specified by their manufacturers, in order to place them on the market as a system")(underlining added)

Maybe rethink with this in mind and see if that changes your conclusion. And otherwise, maybe provide more information about the actual products - allows for better feedback.

Good luck!

------------------------------
Erik Vollebregt
Partner
Amsterdam
Netherlands

Original Message:
Sent: 03-Feb-2022 07:05
From: Richard Jansky
Subject: Handling a System of Accessories

Dear All

In the past I placed medical devices on the EU market. However, now I'm confronted with systems of accessories. So hence, my questions (3).

If I develop a system that has a medical purpose and consists of products, of which none can be claimed by itself to be a medical device as it needs the others (see MDR Art 2 (1, 2)), based on what do I select the one that is the "medical device" and, therefore, the other ones to be its accessories? Do I simply choose the "brain", which coordinates the usage, or do I pick any other "important" product?

Once I decided on the accessories and develop them with their own Declaration of Conformity (DoC), how do I handle the clinical side of the technical documentation (risk management, clinical evalation)? By the MDR concept, accessories have no medical purpose, but are classified as medical devices. Do I stick with the wording of the MDR and say their medical purpose is to enable the medical device?

And thirdly, as I know companies with DoCs containing only accessories, what are the pros & cons of separating their DoCs from those of the medical devices that use them?

I apologize for the density of my questions. It is only because I'm unable to find the answers.

Thank you so much,
Richard

------------------------------
Richard Jansky
Head of RA / RM / QM
Beringen
Switzerland
------------------------------

Hi Anon, hi Anne

This brings me basically back to my initial question.

If I have a device, which is an accessory to a medical device MDR 2(2) and
I choose to create its own Technical Documentation  (for reasons see above)
how do I handle its clinical evaluation, clinical risk assessment ... as it has no medical purpose by itself?

Thanks again,
Richard

------------------------------
Richard Jansky
Head of RA / RM / QM
Beringen
Switzerland
------------------------------

Original Message:
Sent: 09-Feb-2022 14:51
From: Anne LeBlanc
Subject: Handling a System of Accessories

Hi Anon

Check carefully the definition of accessory. If your optional components meet the definition of accessory, then they are devices under the MDR and the device labeling rules are applicable.

------------------------------
Anne LeBlanc
United States

Original Message:
Sent: 07-Feb-2022 03:54
From: Anonymous Member
Subject: Handling a System of Accessories

This message was posted by a user wishing to remain anonymous

Hi RAPS colleagues,

If we combine the accessories (optional) with the main system in the same technical file, is it required that the accessories need be compliant to MDR requirements like having MD symbol, UDI symbols as these accessories are not basically medical devices in itself and doesn't have its own medical intended use.

The expectation from NB is that if we declare some components as accessories then they should be having MD, UDI symbols and other information as per MDR.

Original Message:
Sent: 04-Feb-2022 12:14
From: Erik Vollebregt
Subject: Handling a System of Accessories

Hi Corey, see article 1 (4) of the MDR: "For the purposes of this Regulation, medical devices, accessories for medical devices, and products listed in Annex XVI to which this Regulation applies pursuant to paragraph 2 shall hereinafter be referred to as 'devices'."

Medical devices and accessories are differently defined terms, see article 2 (1) MDR for medical device and 2 (2) for accessory.

Medical device without medical purpose would not be possible under the MDR, because then the element "intended by the manufacturer to be used [...] for one of more of the following specific medical purposes" in article 2 (1) MDR would not be met. See also article 2 (12) which defines the intended purpose: if the manufacturer does not intended the device to be used medically then the device is not a medical device.

This has been clarified by the European Court in the Brain Products case in relation to two versions of the same product (an apparatus for recording brain activity), of which one had a medical intended use, and the other not. So the first is a medical device, and the other a general product - see https://eur-lex.europa.eu/legal-content/en/TXT/?uri=CELEX:62011CJ0219

------------------------------
Erik Vollebregt
Partner
Amsterdam
Netherlands

Original Message:
Sent: 04-Feb-2022 11:50
From: Corey Jaseph
Subject: Handling a System of Accessories

Hi Erik,

Recent discussions have seriously confused me on this topic.

Where in regulations is a device distinguished from a medical device? I was also surprised to hear that devices with no medical purpose are not medical devices. I assumed that "devices with no medical purpose" is the same as "medical devices with no medical purpose."

I would like to have a better understanding of this subject...

Thanks so much for weighing in on this important topic.

------------------------------
Corey Jaseph RAC
Senior Research Analyst
Wheatland CA
United States

Original Message:
Sent: 04-Feb-2022 03:03
From: Erik Vollebregt
Subject: Handling a System of Accessories

Several remarks that may help to untangle this knot for you:

• Accessories are not classified as medical devices but as 'devices', the overarching concept of 'regulated subject matter' under the MDR, covering medical devices, accessories and Annex XVI devices ('non-medical devices').
• A medical device that 'needs' another device is not an accessory as you seem to state, but may also be a compatible or interoperable medical device (see Annex I, point 14.5). Rather with accessory qualification it is the other way around from how you seem to approach it: the device that acts as an accessory to a medical device is the accessory (see the definition in the MDR), not a device that 'needs' another device or product.
• There is nothing in the text of article 22 (1) MDR to prevent you from assembling a system of accessories, because the text does not require that there is a 'main medical device' around which the system revolves or something ("combine devices bearing a CE marking with the following other devices or products, in a manner that is compatible with the intended purpose of the devices or other products and within the limits of use specified by their manufacturers, in order to place them on the market as a system")(underlining added)

Maybe rethink with this in mind and see if that changes your conclusion. And otherwise, maybe provide more information about the actual products - allows for better feedback.

Good luck!

------------------------------
Erik Vollebregt
Partner
Amsterdam
Netherlands

Original Message:
Sent: 03-Feb-2022 07:05
From: Richard Jansky
Subject: Handling a System of Accessories

Dear All

In the past I placed medical devices on the EU market. However, now I'm confronted with systems of accessories. So hence, my questions (3).

If I develop a system that has a medical purpose and consists of products, of which none can be claimed by itself to be a medical device as it needs the others (see MDR Art 2 (1, 2)), based on what do I select the one that is the "medical device" and, therefore, the other ones to be its accessories? Do I simply choose the "brain", which coordinates the usage, or do I pick any other "important" product?

Once I decided on the accessories and develop them with their own Declaration of Conformity (DoC), how do I handle the clinical side of the technical documentation (risk management, clinical evalation)? By the MDR concept, accessories have no medical purpose, but are classified as medical devices. Do I stick with the wording of the MDR and say their medical purpose is to enable the medical device?

And thirdly, as I know companies with DoCs containing only accessories, what are the pros & cons of separating their DoCs from those of the medical devices that use them?

I apologize for the density of my questions. It is only because I'm unable to find the answers.

Thank you so much,
Richard

------------------------------
Richard Jansky
Head of RA / RM / QM
Beringen
Switzerland
------------------------------

Depending on what kind of a thing this system is, I'd imagine that when you're doing a literature search you'll be looking at how users are accomplishing a particular task, using this whole system or similar systems. In that case, I probably wouldn't try to separate them. I'd let the same evaluation be part of both sets of Technical Documentation.

On the other hand, if different accessories or different versions of accessories might be different enough to affect the clinical profile, or have different kinds of available literature, maybe I'd do separate evaluations, and maybe have different timeframes established for re-evaluations...

------------------------------
Anne LeBlanc
United States
------------------------------

Original Message:
Sent: 10-Feb-2022 05:08
From: Richard Jansky
Subject: Handling a System of Accessories

Hi Anon, hi Anne

This brings me basically back to my initial question.

If I have a device, which is an accessory to a medical device MDR 2(2) and
I choose to create its own Technical Documentation  (for reasons see above)
how do I handle its clinical evaluation, clinical risk assessment ... as it has no medical purpose by itself?

Thanks again,
Richard

------------------------------
Richard Jansky
Head of RA / RM / QM
Beringen
Switzerland

Original Message:
Sent: 09-Feb-2022 14:51
From: Anne LeBlanc
Subject: Handling a System of Accessories

Hi Anon

Check carefully the definition of accessory. If your optional components meet the definition of accessory, then they are devices under the MDR and the device labeling rules are applicable.

------------------------------
Anne LeBlanc
United States

Original Message:
Sent: 07-Feb-2022 03:54
From: Anonymous Member
Subject: Handling a System of Accessories

This message was posted by a user wishing to remain anonymous

Hi RAPS colleagues,

If we combine the accessories (optional) with the main system in the same technical file, is it required that the accessories need be compliant to MDR requirements like having MD symbol, UDI symbols as these accessories are not basically medical devices in itself and doesn't have its own medical intended use.

The expectation from NB is that if we declare some components as accessories then they should be having MD, UDI symbols and other information as per MDR.

Original Message:
Sent: 04-Feb-2022 12:14
From: Erik Vollebregt
Subject: Handling a System of Accessories

Hi Corey, see article 1 (4) of the MDR: "For the purposes of this Regulation, medical devices, accessories for medical devices, and products listed in Annex XVI to which this Regulation applies pursuant to paragraph 2 shall hereinafter be referred to as 'devices'."

Medical devices and accessories are differently defined terms, see article 2 (1) MDR for medical device and 2 (2) for accessory.

Medical device without medical purpose would not be possible under the MDR, because then the element "intended by the manufacturer to be used [...] for one of more of the following specific medical purposes" in article 2 (1) MDR would not be met. See also article 2 (12) which defines the intended purpose: if the manufacturer does not intended the device to be used medically then the device is not a medical device.

This has been clarified by the European Court in the Brain Products case in relation to two versions of the same product (an apparatus for recording brain activity), of which one had a medical intended use, and the other not. So the first is a medical device, and the other a general product - see https://eur-lex.europa.eu/legal-content/en/TXT/?uri=CELEX:62011CJ0219

------------------------------
Erik Vollebregt
Partner
Amsterdam
Netherlands

Original Message:
Sent: 04-Feb-2022 11:50
From: Corey Jaseph
Subject: Handling a System of Accessories

Hi Erik,

Recent discussions have seriously confused me on this topic.

Where in regulations is a device distinguished from a medical device? I was also surprised to hear that devices with no medical purpose are not medical devices. I assumed that "devices with no medical purpose" is the same as "medical devices with no medical purpose."

I would like to have a better understanding of this subject...

Thanks so much for weighing in on this important topic.

------------------------------
Corey Jaseph RAC
Senior Research Analyst
Wheatland CA
United States

Original Message:
Sent: 04-Feb-2022 03:03
From: Erik Vollebregt
Subject: Handling a System of Accessories

Several remarks that may help to untangle this knot for you:

• Accessories are not classified as medical devices but as 'devices', the overarching concept of 'regulated subject matter' under the MDR, covering medical devices, accessories and Annex XVI devices ('non-medical devices').
• A medical device that 'needs' another device is not an accessory as you seem to state, but may also be a compatible or interoperable medical device (see Annex I, point 14.5). Rather with accessory qualification it is the other way around from how you seem to approach it: the device that acts as an accessory to a medical device is the accessory (see the definition in the MDR), not a device that 'needs' another device or product.
• There is nothing in the text of article 22 (1) MDR to prevent you from assembling a system of accessories, because the text does not require that there is a 'main medical device' around which the system revolves or something ("combine devices bearing a CE marking with the following other devices or products, in a manner that is compatible with the intended purpose of the devices or other products and within the limits of use specified by their manufacturers, in order to place them on the market as a system")(underlining added)

Maybe rethink with this in mind and see if that changes your conclusion. And otherwise, maybe provide more information about the actual products - allows for better feedback.

Good luck!

------------------------------
Erik Vollebregt
Partner
Amsterdam
Netherlands

Original Message:
Sent: 03-Feb-2022 07:05
From: Richard Jansky
Subject: Handling a System of Accessories

Dear All

In the past I placed medical devices on the EU market. However, now I'm confronted with systems of accessories. So hence, my questions (3).

If I develop a system that has a medical purpose and consists of products, of which none can be claimed by itself to be a medical device as it needs the others (see MDR Art 2 (1, 2)), based on what do I select the one that is the "medical device" and, therefore, the other ones to be its accessories? Do I simply choose the "brain", which coordinates the usage, or do I pick any other "important" product?

Once I decided on the accessories and develop them with their own Declaration of Conformity (DoC), how do I handle the clinical side of the technical documentation (risk management, clinical evalation)? By the MDR concept, accessories have no medical purpose, but are classified as medical devices. Do I stick with the wording of the MDR and say their medical purpose is to enable the medical device?

And thirdly, as I know companies with DoCs containing only accessories, what are the pros & cons of separating their DoCs from those of the medical devices that use them?

I apologize for the density of my questions. It is only because I'm unable to find the answers.

Thank you so much,
Richard

------------------------------
Richard Jansky
Head of RA / RM / QM
Beringen
Switzerland
------------------------------