Regulatory Open Forum

Hi All,

I am very confused by the definition of "procedure pack" under Article 2 of the EU MDR. 

If we pack our device and its accessories together, do we have to claim it is a procedure pack under EU MDR? We didn't need to under MDD and the justification was accepted by the NB. However, EUDAMED requires the manufacturer to select a procedure pack in order to register a package containing two different CE-marked medical devices. Does that mean EU MDR requires all the packages containing the devices and their accessories to be registered under a procedure pack (or system)?

Any opinion? 

Thanks.

Regards, 

Hi Ning,

this is difficult to answer without more details (and of course because the MDR is not always very clear on things and aside from UDI assignment I think there currently is no detailed guidance or Q&A document on systems and procedure packs under the MDR.).

Maybe a few thoughts:

The general concept of systems/procedure packs is not new to the MDR and while the definitions were added I do not think that is is substantially different from what was required under the MDD. So if you had a viable justification under the MDD why your combination of products was no procedure pack, this in theory should still hold up under the MDR.

However, the MDR extends and centralises the registration requirements that under the MDD were to a large degree part of the national legislation. If your justification depended on specific national registration requriements, this might have changed now.

In general I guess if you have different CE-marked medical devices that are meant to be used for a common medical purpose, you package them together and market them under a single article number, then this probably is a procedure pack and needs to be registered separately (along with a separate registration as "system and procedure pack producer"). The only way to circumvent this would be, if the initial conformity assessment procedure was made for the procedure pack itself, including all accessories. It then might be possible to use the "configurable device" concept established in MDR Annex VI, Part C. As far as I can see, this is a new concept and the interpretation is not trivial and highly dependent on the individual case.

What makes things worse at the moment is that Eudamed is not fully functional and might add or change functionality that currently causes your problems with registration. And as long as there is no full functionality, in theory the "old" registration requirements are still applicable.

I hope this helps as a starting point. If you would like a more detailed opinion on your specific case, maybe contact me directly.

Best regards,

Christoph

Hi All,

I am very confused by the definition of "procedure pack" under Article 2 of the EU MDR. 

If we pack our device and its accessories together, do we have to claim it is a procedure pack under EU MDR? We didn't need to under MDD and the justification was accepted by the NB. However, EUDAMED requires the manufacturer to select a procedure pack in order to register a package containing two different CE-marked medical devices. Does that mean EU MDR requires all the packages containing the devices and their accessories to be registered under a procedure pack (or system)?

Any opinion? 

Thanks.

Regards, 

Good day Ning,

You are not alone in mis-understanding of the Procedure Pack under Article 22 of the EU MDR (Article 11 under the EU MDD).  There are different interpretations for a Procedure Pack as well, so ultimately you can have a discussion with your Notified Body about the approach and see if they agree.  Just note, when approaching a Notified Body (or another regulatory agency such as a Competent Authority) tell them your decision, strategy, and approach for your products and gain their acceptance.  The worst thing to do is say: 'Here is our Product A, what do you think?'  Because you will get the most conservative answer from them.  Tell them your strategy, reasons why, and justifications, so it is clear for them to agree with the approach.

This is my personal opinion and thoughts on Procedure Packs.  When putting accessories in a carton box or shipping box along with the main product this would not be a Procedure Pack by definition because these products are being sold together (or separately) though are still part of the same intended use.  Meaning the main product can or can not use the accessories along with the main product to make it functional.  A Procedure Pack is when different CE Marked products from different Manufacturers are put together are sold as a "convenience kit" (an FDA term) or sold together to make it easier for the user having all of the needing products together in one package.

If you sell the main product with accessories, these would still may have different entries in the EUDAMED system, but they would not be considered a Procedure Pack.  They most likely would each have their own UDI assignment as well.  But again not a procedure pack if you are selling them all through your own company.  As Christoph mentioned it is really important to note that EUDAMED is not fully functional and is still changing ... quite often, so until the EUDAMED system is stable or further Guidance concerning Procedure Packs are provided, this will probably still remain for interpretation by different individuals and regulators.

Hi Ning,

this is difficult to answer without more details (and of course because the MDR is not always very clear on things and aside from UDI assignment I think there currently is no detailed guidance or Q&A document on systems and procedure packs under the MDR.).

Maybe a few thoughts:

The general concept of systems/procedure packs is not new to the MDR and while the definitions were added I do not think that is is substantially different from what was required under the MDD. So if you had a viable justification under the MDD why your combination of products was no procedure pack, this in theory should still hold up under the MDR.

However, the MDR extends and centralises the registration requirements that under the MDD were to a large degree part of the national legislation. If your justification depended on specific national registration requriements, this might have changed now.

In general I guess if you have different CE-marked medical devices that are meant to be used for a common medical purpose, you package them together and market them under a single article number, then this probably is a procedure pack and needs to be registered separately (along with a separate registration as "system and procedure pack producer"). The only way to circumvent this would be, if the initial conformity assessment procedure was made for the procedure pack itself, including all accessories. It then might be possible to use the "configurable device" concept established in MDR Annex VI, Part C. As far as I can see, this is a new concept and the interpretation is not trivial and highly dependent on the individual case.

What makes things worse at the moment is that Eudamed is not fully functional and might add or change functionality that currently causes your problems with registration. And as long as there is no full functionality, in theory the "old" registration requirements are still applicable.

I hope this helps as a starting point. If you would like a more detailed opinion on your specific case, maybe contact me directly.

Best regards,

Christoph

Hi All,

I am very confused by the definition of "procedure pack" under Article 2 of the EU MDR. 

If we pack our device and its accessories together, do we have to claim it is a procedure pack under EU MDR? We didn't need to under MDD and the justification was accepted by the NB. However, EUDAMED requires the manufacturer to select a procedure pack in order to register a package containing two different CE-marked medical devices. Does that mean EU MDR requires all the packages containing the devices and their accessories to be registered under a procedure pack (or system)?

Any opinion? 

Thanks.

Regards, 

Ning, I agree with Cristoph when he says: "if you have different CE-marked medical devices that are meant to be used for a common medical purpose, you package them together and market them under a single article number, then this probably is a procedure pack."

The definition in the MDR is substantially the same as it was under the MDD, and in neither does it say anything about applying only when the items being sold together come from different manufacturers.

One way round this that I used under the MDD is NOT to sell the combination of devices under a single article number, but as individual items, each with its own article number. You can still pack them together for shipment, but the quotation would include multiple article numbers, each with an associated price. By the way, for anyone with long memories, this approach was endorsed by Norbert Anselmann.

That's my experience, anyway.

------------------------------
Roger Gray
VP Quality and Regulatory
Donawa Lifescience
Clinical Studies - Regulatory - Quality Systems
AR/UKRP services
Italy and UK
rgray@donawa.com
www.donawa.com

Original Message:
Sent: 17-Mar-2023 05:55
From: Richard Vincins
Subject: EU MDR Procedure Pack

Good day Ning,

You are not alone in mis-understanding of the Procedure Pack under Article 22 of the EU MDR (Article 11 under the EU MDD).  There are different interpretations for a Procedure Pack as well, so ultimately you can have a discussion with your Notified Body about the approach and see if they agree.  Just note, when approaching a Notified Body (or another regulatory agency such as a Competent Authority) tell them your decision, strategy, and approach for your products and gain their acceptance.  The worst thing to do is say: 'Here is our Product A, what do you think?'  Because you will get the most conservative answer from them.  Tell them your strategy, reasons why, and justifications, so it is clear for them to agree with the approach.

This is my personal opinion and thoughts on Procedure Packs.  When putting accessories in a carton box or shipping box along with the main product this would not be a Procedure Pack by definition because these products are being sold together (or separately) though are still part of the same intended use.  Meaning the main product can or can not use the accessories along with the main product to make it functional.  A Procedure Pack is when different CE Marked products from different Manufacturers are put together are sold as a "convenience kit" (an FDA term) or sold together to make it easier for the user having all of the needing products together in one package.

If you sell the main product with accessories, these would still may have different entries in the EUDAMED system, but they would not be considered a Procedure Pack.  They most likely would each have their own UDI assignment as well.  But again not a procedure pack if you are selling them all through your own company.  As Christoph mentioned it is really important to note that EUDAMED is not fully functional and is still changing ... quite often, so until the EUDAMED system is stable or further Guidance concerning Procedure Packs are provided, this will probably still remain for interpretation by different individuals and regulators.

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

Original Message:
Sent: 17-Mar-2023 03:55
From: Christoph Kiesselbach
Subject: EU MDR Procedure Pack

Hi Ning,

this is difficult to answer without more details (and of course because the MDR is not always very clear on things and aside from UDI assignment I think there currently is no detailed guidance or Q&A document on systems and procedure packs under the MDR.).

Maybe a few thoughts:

The general concept of systems/procedure packs is not new to the MDR and while the definitions were added I do not think that is is substantially different from what was required under the MDD. So if you had a viable justification under the MDD why your combination of products was no procedure pack, this in theory should still hold up under the MDR.

However, the MDR extends and centralises the registration requirements that under the MDD were to a large degree part of the national legislation. If your justification depended on specific national registration requriements, this might have changed now.

In general I guess if you have different CE-marked medical devices that are meant to be used for a common medical purpose, you package them together and market them under a single article number, then this probably is a procedure pack and needs to be registered separately (along with a separate registration as "system and procedure pack producer"). The only way to circumvent this would be, if the initial conformity assessment procedure was made for the procedure pack itself, including all accessories. It then might be possible to use the "configurable device" concept established in MDR Annex VI, Part C. As far as I can see, this is a new concept and the interpretation is not trivial and highly dependent on the individual case.

What makes things worse at the moment is that Eudamed is not fully functional and might add or change functionality that currently causes your problems with registration. And as long as there is no full functionality, in theory the "old" registration requirements are still applicable.

I hope this helps as a starting point. If you would like a more detailed opinion on your specific case, maybe contact me directly.

Best regards,

Christoph

------------------------------
Christoph Kiesselbach
Reutlingen
Germany

Original Message:
Sent: 16-Mar-2023 13:05
From: Ning Wang
Subject: EU MDR Procedure Pack

Hi All,

I am very confused by the definition of "procedure pack" under Article 2 of the EU MDR. 

If we pack our device and its accessories together, do we have to claim it is a procedure pack under EU MDR? We didn't need to under MDD and the justification was accepted by the NB. However, EUDAMED requires the manufacturer to select a procedure pack in order to register a package containing two different CE-marked medical devices. Does that mean EU MDR requires all the packages containing the devices and their accessories to be registered under a procedure pack (or system)?

Any opinion? 

Thanks.

Regards, 

------------------------------
Ning
RA Manager


------------------------------

Thank you, Roger, Richard and Cristoph. 

In this particular case, the accessory is optional to the device and both the accessory and medical device are manufactured (& CE marked) by us. We only pack them together in a carton box. After reading your comments, this is very unlikely to be a procedure pack, although it is not yet possible to register this carton box under EUDEMED. 

------------------------------
Ning Wang
RA Manager
United Kingdom

Original Message:
Sent: 17-Mar-2023 06:48
From: Roger Gray
Subject: EU MDR Procedure Pack

Ning, I agree with Cristoph when he says: "if you have different CE-marked medical devices that are meant to be used for a common medical purpose, you package them together and market them under a single article number, then this probably is a procedure pack."

The definition in the MDR is substantially the same as it was under the MDD, and in neither does it say anything about applying only when the items being sold together come from different manufacturers.

One way round this that I used under the MDD is NOT to sell the combination of devices under a single article number, but as individual items, each with its own article number. You can still pack them together for shipment, but the quotation would include multiple article numbers, each with an associated price. By the way, for anyone with long memories, this approach was endorsed by Norbert Anselmann.

That's my experience, anyway.

------------------------------
Roger Gray
VP Quality and Regulatory
Donawa Lifescience
Clinical Studies - Regulatory - Quality Systems
AR/UKRP services
Italy and UK
rgray@donawa.com
www.donawa.com

Original Message:
Sent: 17-Mar-2023 05:55
From: Richard Vincins
Subject: EU MDR Procedure Pack

Good day Ning,

You are not alone in mis-understanding of the Procedure Pack under Article 22 of the EU MDR (Article 11 under the EU MDD).  There are different interpretations for a Procedure Pack as well, so ultimately you can have a discussion with your Notified Body about the approach and see if they agree.  Just note, when approaching a Notified Body (or another regulatory agency such as a Competent Authority) tell them your decision, strategy, and approach for your products and gain their acceptance.  The worst thing to do is say: 'Here is our Product A, what do you think?'  Because you will get the most conservative answer from them.  Tell them your strategy, reasons why, and justifications, so it is clear for them to agree with the approach.

This is my personal opinion and thoughts on Procedure Packs.  When putting accessories in a carton box or shipping box along with the main product this would not be a Procedure Pack by definition because these products are being sold together (or separately) though are still part of the same intended use.  Meaning the main product can or can not use the accessories along with the main product to make it functional.  A Procedure Pack is when different CE Marked products from different Manufacturers are put together are sold as a "convenience kit" (an FDA term) or sold together to make it easier for the user having all of the needing products together in one package.

If you sell the main product with accessories, these would still may have different entries in the EUDAMED system, but they would not be considered a Procedure Pack.  They most likely would each have their own UDI assignment as well.  But again not a procedure pack if you are selling them all through your own company.  As Christoph mentioned it is really important to note that EUDAMED is not fully functional and is still changing ... quite often, so until the EUDAMED system is stable or further Guidance concerning Procedure Packs are provided, this will probably still remain for interpretation by different individuals and regulators.

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

Original Message:
Sent: 17-Mar-2023 03:55
From: Christoph Kiesselbach
Subject: EU MDR Procedure Pack

Hi Ning,

this is difficult to answer without more details (and of course because the MDR is not always very clear on things and aside from UDI assignment I think there currently is no detailed guidance or Q&A document on systems and procedure packs under the MDR.).

Maybe a few thoughts:

The general concept of systems/procedure packs is not new to the MDR and while the definitions were added I do not think that is is substantially different from what was required under the MDD. So if you had a viable justification under the MDD why your combination of products was no procedure pack, this in theory should still hold up under the MDR.

However, the MDR extends and centralises the registration requirements that under the MDD were to a large degree part of the national legislation. If your justification depended on specific national registration requriements, this might have changed now.

In general I guess if you have different CE-marked medical devices that are meant to be used for a common medical purpose, you package them together and market them under a single article number, then this probably is a procedure pack and needs to be registered separately (along with a separate registration as "system and procedure pack producer"). The only way to circumvent this would be, if the initial conformity assessment procedure was made for the procedure pack itself, including all accessories. It then might be possible to use the "configurable device" concept established in MDR Annex VI, Part C. As far as I can see, this is a new concept and the interpretation is not trivial and highly dependent on the individual case.

What makes things worse at the moment is that Eudamed is not fully functional and might add or change functionality that currently causes your problems with registration. And as long as there is no full functionality, in theory the "old" registration requirements are still applicable.

I hope this helps as a starting point. If you would like a more detailed opinion on your specific case, maybe contact me directly.

Best regards,

Christoph

------------------------------
Christoph Kiesselbach
Reutlingen
Germany

Original Message:
Sent: 16-Mar-2023 13:05
From: Ning Wang
Subject: EU MDR Procedure Pack

Hi All,

I am very confused by the definition of "procedure pack" under Article 2 of the EU MDR. 

If we pack our device and its accessories together, do we have to claim it is a procedure pack under EU MDR? We didn't need to under MDD and the justification was accepted by the NB. However, EUDAMED requires the manufacturer to select a procedure pack in order to register a package containing two different CE-marked medical devices. Does that mean EU MDR requires all the packages containing the devices and their accessories to be registered under a procedure pack (or system)?

Any opinion? 

Thanks.

Regards, 

------------------------------
Ning
RA Manager


------------------------------

Hi All,

I am very confused by the definition of "procedure pack" under Article 2 of the EU MDR. 

If we pack our device and its accessories together, do we have to claim it is a procedure pack under EU MDR? We didn't need to under MDD and the justification was accepted by the NB. However, EUDAMED requires the manufacturer to select a procedure pack in order to register a package containing two different CE-marked medical devices. Does that mean EU MDR requires all the packages containing the devices and their accessories to be registered under a procedure pack (or system)?

Any opinion? 

Thanks.

Regards, 

------------------------------
Ning
RA Manager


------------------------------

Hi Ning

An "accessory to a medical" is not a medical device according to Article 2(2), consequently does not carry a CE mark and Article 22(4) applies as quoted below.

"Where the system or procedure pack incorporates devices which do not bear the CE marking or where the chosen combination of devices is not compatible in view of their original intended purpose, or where the sterilisation has not been carried out in accordance with the manu­ facturer's instructions, the system or procedure pack shall be treated as a device in its own right and shall be subject to the relevant conformity assessment procedure pursuant to Article 52. The natural or legal person shall assume the obligations incumbent on manufacturers."

With regards to former comments, please keep in mind that intended purpose is mentioned within Article 22, not the intended use.

Some notified bodies consider intended use and intended purpose to be different based on the associated MDR text, regardless of the non-legally binding MDCG which states that they are the same. One interpretation of intended purpose = intended use + indications + use environment + ….etc (based on MDR Article 2(12))

Unfortunately, the MDR does not include the definition for "intended use" within Article 2 Definitions and make a clear distinction between intended use and intended purpose.

Best Regards,

Stephanie

------------------------------
Stephanie Grassmann
Founder & Managing Director of MedTechXperts Ltd
Biberstein
Switzerland

Original Message:
Sent: 16-Mar-2023 13:05
From: Ning Wang
Subject: EU MDR Procedure Pack

Hi All,

I am very confused by the definition of "procedure pack" under Article 2 of the EU MDR. 

If we pack our device and its accessories together, do we have to claim it is a procedure pack under EU MDR? We didn't need to under MDD and the justification was accepted by the NB. However, EUDAMED requires the manufacturer to select a procedure pack in order to register a package containing two different CE-marked medical devices. Does that mean EU MDR requires all the packages containing the devices and their accessories to be registered under a procedure pack (or system)?

Any opinion? 

Thanks.

Regards, 

------------------------------
Ning
RA Manager


------------------------------

Hi Stephanie,

this might be a misunderstanding: Accessories according to Article 2(2) are no medical devices, but they are devices in their own right according to Article 1(4) and can (and in some cases must) be separately CE-marked (Article 20(1) references "devices" not "medical devices"). And I think that is the case here: The medical device and its accessory have been developned and are for sale independently and are both CE-marked.

Best regards

Christoph

------------------------------
Christoph Kiesselbach
Reutlingen
Germany

Original Message:
Sent: 18-Mar-2023 05:32
From: Stephanie Grassmann
Subject: EU MDR Procedure Pack

Hi Ning

An "accessory to a medical" is not a medical device according to Article 2(2), consequently does not carry a CE mark and Article 22(4) applies as quoted below.

"Where the system or procedure pack incorporates devices which do not bear the CE marking or where the chosen combination of devices is not compatible in view of their original intended purpose, or where the sterilisation has not been carried out in accordance with the manu­ facturer's instructions, the system or procedure pack shall be treated as a device in its own right and shall be subject to the relevant conformity assessment procedure pursuant to Article 52. The natural or legal person shall assume the obligations incumbent on manufacturers."

With regards to former comments, please keep in mind that intended purpose is mentioned within Article 22, not the intended use.

Some notified bodies consider intended use and intended purpose to be different based on the associated MDR text, regardless of the non-legally binding MDCG which states that they are the same. One interpretation of intended purpose = intended use + indications + use environment + ….etc (based on MDR Article 2(12))

Unfortunately, the MDR does not include the definition for "intended use" within Article 2 Definitions and make a clear distinction between intended use and intended purpose.

Best Regards,

Stephanie

------------------------------
Stephanie Grassmann
Founder & Managing Director of MedTechXperts Ltd
Biberstein
Switzerland

Original Message:
Sent: 16-Mar-2023 13:05
From: Ning Wang
Subject: EU MDR Procedure Pack

Hi All,

I am very confused by the definition of "procedure pack" under Article 2 of the EU MDR. 

If we pack our device and its accessories together, do we have to claim it is a procedure pack under EU MDR? We didn't need to under MDD and the justification was accepted by the NB. However, EUDAMED requires the manufacturer to select a procedure pack in order to register a package containing two different CE-marked medical devices. Does that mean EU MDR requires all the packages containing the devices and their accessories to be registered under a procedure pack (or system)?

Any opinion? 

Thanks.

Regards, 

------------------------------
Ning
RA Manager


------------------------------

Dear Christoph

Yes, agreed an accessory is not a medical device. Thereby, an accessory cannot be CE marked as a medical device. 

CE mark represents that a product falls under the definition of harmonised regulation in the Union. If you believe that the accessory has a CE mark then under which harmonised regulation?

An example: if the accessory fulfils the definition of the PPE product  (personal protective equipment; EU Regulation 2016/425) then yes it can be CE marked as PPE product under the PPE regulation. If, however, the accessory does not fall under the definition of any Union harmonised regulation then the product is not allowed to be CE marked.

Best Regards,

Stephanie 

------------------------------
Stephanie Grassmann
Founder & Managing Director of MedTechXperts Ltd
Biberstein
Switzerland

Original Message:
Sent: 20-Mar-2023 05:32
From: Christoph Kiesselbach
Subject: EU MDR Procedure Pack

Hi Stephanie,

this might be a misunderstanding: Accessories according to Article 2(2) are no medical devices, but they are devices in their own right according to Article 1(4) and can (and in some cases must) be separately CE-marked (Article 20(1) references "devices" not "medical devices"). And I think that is the case here: The medical device and its accessory have been developned and are for sale independently and are both CE-marked.

Best regards

Christoph

------------------------------
Christoph Kiesselbach
Reutlingen
Germany

Original Message:
Sent: 18-Mar-2023 05:32
From: Stephanie Grassmann
Subject: EU MDR Procedure Pack

Hi Ning

An "accessory to a medical" is not a medical device according to Article 2(2), consequently does not carry a CE mark and Article 22(4) applies as quoted below.

"Where the system or procedure pack incorporates devices which do not bear the CE marking or where the chosen combination of devices is not compatible in view of their original intended purpose, or where the sterilisation has not been carried out in accordance with the manu­ facturer's instructions, the system or procedure pack shall be treated as a device in its own right and shall be subject to the relevant conformity assessment procedure pursuant to Article 52. The natural or legal person shall assume the obligations incumbent on manufacturers."

With regards to former comments, please keep in mind that intended purpose is mentioned within Article 22, not the intended use.

Some notified bodies consider intended use and intended purpose to be different based on the associated MDR text, regardless of the non-legally binding MDCG which states that they are the same. One interpretation of intended purpose = intended use + indications + use environment + ….etc (based on MDR Article 2(12))

Unfortunately, the MDR does not include the definition for "intended use" within Article 2 Definitions and make a clear distinction between intended use and intended purpose.

Best Regards,

Stephanie

------------------------------
Stephanie Grassmann
Founder & Managing Director of MedTechXperts Ltd
Biberstein
Switzerland

Original Message:
Sent: 16-Mar-2023 13:05
From: Ning Wang
Subject: EU MDR Procedure Pack

Hi All,

I am very confused by the definition of "procedure pack" under Article 2 of the EU MDR. 

If we pack our device and its accessories together, do we have to claim it is a procedure pack under EU MDR? We didn't need to under MDD and the justification was accepted by the NB. However, EUDAMED requires the manufacturer to select a procedure pack in order to register a package containing two different CE-marked medical devices. Does that mean EU MDR requires all the packages containing the devices and their accessories to be registered under a procedure pack (or system)?

Any opinion? 

Thanks.

Regards, 

------------------------------
Ning
RA Manager


------------------------------

Dear Stephanie,

maybe let's just agree to disagree.

Just to clarify my point of view:

As far as I can see, accessories to medical devices (in the specific meaning of Article 2(2)) are explicitely covered by the MDR according to Article 1(1):

"This Regulation lays down rules concerning the placing on the market, making available on the market or putting into service of medical devices for human use and accessories for such devices in the Union."

They are included in the definition of a "device" in Article 1(4), are therefore covered by all MDR requirements addressing "devices" (so most requirements) and they are e.g. classified in their own right (Annex VIII, 3.2, see MDCG 2021-24 for examples). So I think they absolutely can be CE-marked under the MDR without the need for any other EU regulation to be applied.

Best regards

Christoph

Dear Christoph

Yes, agreed an accessory is not a medical device. Thereby, an accessory cannot be CE marked as a medical device. 

CE mark represents that a product falls under the definition of harmonised regulation in the Union. If you believe that the accessory has a CE mark then under which harmonised regulation?

An example: if the accessory fulfils the definition of the PPE product  (personal protective equipment; EU Regulation 2016/425) then yes it can be CE marked as PPE product under the PPE regulation. If, however, the accessory does not fall under the definition of any Union harmonised regulation then the product is not allowed to be CE marked.

Best Regards,

Stephanie 

------------------------------
Stephanie Grassmann
Founder & Managing Director of MedTechXperts Ltd
Biberstein
Switzerland

Original Message:
Sent: 20-Mar-2023 05:32
From: Christoph Kiesselbach
Subject: EU MDR Procedure Pack

Hi Stephanie,

this might be a misunderstanding: Accessories according to Article 2(2) are no medical devices, but they are devices in their own right according to Article 1(4) and can (and in some cases must) be separately CE-marked (Article 20(1) references "devices" not "medical devices"). And I think that is the case here: The medical device and its accessory have been developned and are for sale independently and are both CE-marked.

Best regards

Christoph

------------------------------
Christoph Kiesselbach
Reutlingen
Germany

Original Message:
Sent: 18-Mar-2023 05:32
From: Stephanie Grassmann
Subject: EU MDR Procedure Pack

Hi Ning

An "accessory to a medical" is not a medical device according to Article 2(2), consequently does not carry a CE mark and Article 22(4) applies as quoted below.

"Where the system or procedure pack incorporates devices which do not bear the CE marking or where the chosen combination of devices is not compatible in view of their original intended purpose, or where the sterilisation has not been carried out in accordance with the manu­ facturer's instructions, the system or procedure pack shall be treated as a device in its own right and shall be subject to the relevant conformity assessment procedure pursuant to Article 52. The natural or legal person shall assume the obligations incumbent on manufacturers."

With regards to former comments, please keep in mind that intended purpose is mentioned within Article 22, not the intended use.

Some notified bodies consider intended use and intended purpose to be different based on the associated MDR text, regardless of the non-legally binding MDCG which states that they are the same. One interpretation of intended purpose = intended use + indications + use environment + ….etc (based on MDR Article 2(12))

Unfortunately, the MDR does not include the definition for "intended use" within Article 2 Definitions and make a clear distinction between intended use and intended purpose.

Best Regards,

Stephanie

------------------------------
Stephanie Grassmann
Founder & Managing Director of MedTechXperts Ltd
Biberstein
Switzerland

Original Message:
Sent: 16-Mar-2023 13:05
From: Ning Wang
Subject: EU MDR Procedure Pack

Hi All,

I am very confused by the definition of "procedure pack" under Article 2 of the EU MDR. 

If we pack our device and its accessories together, do we have to claim it is a procedure pack under EU MDR? We didn't need to under MDD and the justification was accepted by the NB. However, EUDAMED requires the manufacturer to select a procedure pack in order to register a package containing two different CE-marked medical devices. Does that mean EU MDR requires all the packages containing the devices and their accessories to be registered under a procedure pack (or system)?

Any opinion? 

Thanks.

Regards, 

------------------------------
Ning
RA Manager


------------------------------

Dear Stephanie,

maybe let's just agree to disagree.

Just to clarify my point of view:

As far as I can see, accessories to medical devices (in the specific meaning of Article 2(2)) are explicitely covered by the MDR according to Article 1(1):

"This Regulation lays down rules concerning the placing on the market, making available on the market or putting into service of medical devices for human use and accessories for such devices in the Union."

They are included in the definition of a "device" in Article 1(4), are therefore covered by all MDR requirements addressing "devices" (so most requirements) and they are e.g. classified in their own right (Annex VIII, 3.2, see MDCG 2021-24 for examples). So I think they absolutely can be CE-marked under the MDR without the need for any other EU regulation to be applied.

Best regards

Christoph

Dear Christoph

Yes, agreed an accessory is not a medical device. Thereby, an accessory cannot be CE marked as a medical device. 

CE mark represents that a product falls under the definition of harmonised regulation in the Union. If you believe that the accessory has a CE mark then under which harmonised regulation?

An example: if the accessory fulfils the definition of the PPE product  (personal protective equipment; EU Regulation 2016/425) then yes it can be CE marked as PPE product under the PPE regulation. If, however, the accessory does not fall under the definition of any Union harmonised regulation then the product is not allowed to be CE marked.

Best Regards,

Stephanie 

------------------------------
Stephanie Grassmann
Founder & Managing Director of MedTechXperts Ltd
Biberstein
Switzerland

Original Message:
Sent: 20-Mar-2023 05:32
From: Christoph Kiesselbach
Subject: EU MDR Procedure Pack

Hi Stephanie,

this might be a misunderstanding: Accessories according to Article 2(2) are no medical devices, but they are devices in their own right according to Article 1(4) and can (and in some cases must) be separately CE-marked (Article 20(1) references "devices" not "medical devices"). And I think that is the case here: The medical device and its accessory have been developned and are for sale independently and are both CE-marked.

Best regards

Christoph

------------------------------
Christoph Kiesselbach
Reutlingen
Germany

Original Message:
Sent: 18-Mar-2023 05:32
From: Stephanie Grassmann
Subject: EU MDR Procedure Pack

Hi Ning

An "accessory to a medical" is not a medical device according to Article 2(2), consequently does not carry a CE mark and Article 22(4) applies as quoted below.

"Where the system or procedure pack incorporates devices which do not bear the CE marking or where the chosen combination of devices is not compatible in view of their original intended purpose, or where the sterilisation has not been carried out in accordance with the manu­ facturer's instructions, the system or procedure pack shall be treated as a device in its own right and shall be subject to the relevant conformity assessment procedure pursuant to Article 52. The natural or legal person shall assume the obligations incumbent on manufacturers."

With regards to former comments, please keep in mind that intended purpose is mentioned within Article 22, not the intended use.

Some notified bodies consider intended use and intended purpose to be different based on the associated MDR text, regardless of the non-legally binding MDCG which states that they are the same. One interpretation of intended purpose = intended use + indications + use environment + ….etc (based on MDR Article 2(12))

Unfortunately, the MDR does not include the definition for "intended use" within Article 2 Definitions and make a clear distinction between intended use and intended purpose.

Best Regards,

Stephanie

------------------------------
Stephanie Grassmann
Founder & Managing Director of MedTechXperts Ltd
Biberstein
Switzerland

Original Message:
Sent: 16-Mar-2023 13:05
From: Ning Wang
Subject: EU MDR Procedure Pack

Hi All,

I am very confused by the definition of "procedure pack" under Article 2 of the EU MDR. 

If we pack our device and its accessories together, do we have to claim it is a procedure pack under EU MDR? We didn't need to under MDD and the justification was accepted by the NB. However, EUDAMED requires the manufacturer to select a procedure pack in order to register a package containing two different CE-marked medical devices. Does that mean EU MDR requires all the packages containing the devices and their accessories to be registered under a procedure pack (or system)?

Any opinion? 

Thanks.

Regards, 

------------------------------
Ning
RA Manager


------------------------------

Dear Christoph

Thank you for coming back to this point and challenging me. 

Wishing that they had used the word "device" in their definition of 'accessory for a medical device" instead they use the word 'article'. 

"'accessory for a medical device' means an article which, whilst not being itself a medical device'.....

According to Article 1(4), they state ".....shall hereinafter be referred to as 'devices'"

-> No they did not in Article 2(2): the word "article" and not "device" was used in the definition of accessories. 

Best Regards,

Stephanie

Dear Stephanie,

maybe let's just agree to disagree.

Just to clarify my point of view:

As far as I can see, accessories to medical devices (in the specific meaning of Article 2(2)) are explicitely covered by the MDR according to Article 1(1):

"This Regulation lays down rules concerning the placing on the market, making available on the market or putting into service of medical devices for human use and accessories for such devices in the Union."

They are included in the definition of a "device" in Article 1(4), are therefore covered by all MDR requirements addressing "devices" (so most requirements) and they are e.g. classified in their own right (Annex VIII, 3.2, see MDCG 2021-24 for examples). So I think they absolutely can be CE-marked under the MDR without the need for any other EU regulation to be applied.

Best regards

Christoph

Dear Christoph

Yes, agreed an accessory is not a medical device. Thereby, an accessory cannot be CE marked as a medical device. 

CE mark represents that a product falls under the definition of harmonised regulation in the Union. If you believe that the accessory has a CE mark then under which harmonised regulation?

An example: if the accessory fulfils the definition of the PPE product  (personal protective equipment; EU Regulation 2016/425) then yes it can be CE marked as PPE product under the PPE regulation. If, however, the accessory does not fall under the definition of any Union harmonised regulation then the product is not allowed to be CE marked.

Best Regards,

Stephanie 

------------------------------
Stephanie Grassmann
Founder & Managing Director of MedTechXperts Ltd
Biberstein
Switzerland

Original Message:
Sent: 20-Mar-2023 05:32
From: Christoph Kiesselbach
Subject: EU MDR Procedure Pack

Hi Stephanie,

this might be a misunderstanding: Accessories according to Article 2(2) are no medical devices, but they are devices in their own right according to Article 1(4) and can (and in some cases must) be separately CE-marked (Article 20(1) references "devices" not "medical devices"). And I think that is the case here: The medical device and its accessory have been developned and are for sale independently and are both CE-marked.

Best regards

Christoph

------------------------------
Christoph Kiesselbach
Reutlingen
Germany

Original Message:
Sent: 18-Mar-2023 05:32
From: Stephanie Grassmann
Subject: EU MDR Procedure Pack

Hi Ning

An "accessory to a medical" is not a medical device according to Article 2(2), consequently does not carry a CE mark and Article 22(4) applies as quoted below.

"Where the system or procedure pack incorporates devices which do not bear the CE marking or where the chosen combination of devices is not compatible in view of their original intended purpose, or where the sterilisation has not been carried out in accordance with the manu­ facturer's instructions, the system or procedure pack shall be treated as a device in its own right and shall be subject to the relevant conformity assessment procedure pursuant to Article 52. The natural or legal person shall assume the obligations incumbent on manufacturers."

With regards to former comments, please keep in mind that intended purpose is mentioned within Article 22, not the intended use.

Some notified bodies consider intended use and intended purpose to be different based on the associated MDR text, regardless of the non-legally binding MDCG which states that they are the same. One interpretation of intended purpose = intended use + indications + use environment + ….etc (based on MDR Article 2(12))

Unfortunately, the MDR does not include the definition for "intended use" within Article 2 Definitions and make a clear distinction between intended use and intended purpose.

Best Regards,

Stephanie

------------------------------
Stephanie Grassmann
Founder & Managing Director of MedTechXperts Ltd
Biberstein
Switzerland

Original Message:
Sent: 16-Mar-2023 13:05
From: Ning Wang
Subject: EU MDR Procedure Pack

Hi All,

I am very confused by the definition of "procedure pack" under Article 2 of the EU MDR. 

If we pack our device and its accessories together, do we have to claim it is a procedure pack under EU MDR? We didn't need to under MDD and the justification was accepted by the NB. However, EUDAMED requires the manufacturer to select a procedure pack in order to register a package containing two different CE-marked medical devices. Does that mean EU MDR requires all the packages containing the devices and their accessories to be registered under a procedure pack (or system)?

Any opinion? 

Thanks.

Regards, 

------------------------------
Ning
RA Manager


------------------------------