Regulatory Open Forum

Hello,

We are based in the EU and are finishing the technical files for the MDR review. 


We have a sterile single use device (Class IIa) sold in boxes of 10. This medical device does not require a notice. 


In the box of 10, we put an accessory (a non sterile, resuable adaptor). It is OK for >10 reuses / sterilisation cycles. An IFU will go in the box to explain how to resterilise the adaptor.  

Does anyone have any advice, how the two items should be marked on the packaging? 

e.g. 
Sterile                                                                                                          Non sterile
x 10                                                                                                                x1
[picture of the device]                                                                            [picture of the accessory]    


"appplicable for [device name] only"                                          no symbols for the acessory - because it is not a MD? 
[Sterile symbol] [do not reuse] [MD symbols etc...]                           or... "applicable for [accessory] only"
                                                                                                                          [non sterile symbol] [etc...]


The space is limited and I want to avoid having to fit 10 translations of 
"appplicable for [device name] only"     
"applicable for [accessory] only" 

Would this trigger the pack being considered a Procedure Pack under Article 22? 


Thanks for your ideas :-)



------------------------------
Tom Morrison
Q&RA Officer
France
------------------------------

Yes, in my view, you should consider this an assembly under MDR Article 22, Tom, which requires assemblies such as this to be "accompanied by the information referred to in Section 23 of Annex I."

Section 23 provides a clear indication of what information should appear where, although there is plenty of latitude regarding exactly how the labeling requirements can be achieved.

Your suggestion for the outer pack seems reasonable to me, but with regard to your question: "no symbols for the accessory - because it is not a MD?", symbols are still ok to be used for the accessory, in accordance with Annex I, 23.1(h), viz: "Where appropriate, the information supplied by the manufacturer shall take the form of internationally recognised symbols."

Hope this is helpful.

------------------------------
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: 20-Apr-2022 10:49
From: thomas morrison
Subject: Labelling Advice - Nont sterile Reusable Accessory + sterile single use device

Hello,

We are based in the EU and are finishing the technical files for the MDR review.


We have a sterile single use device (Class IIa) sold in boxes of 10. This medical device does not require a notice.


In the box of 10, we put an accessory (a non sterile, resuable adaptor). It is OK for >10 reuses / sterilisation cycles. An IFU will go in the box to explain how to resterilise the adaptor.

Does anyone have any advice, how the two items should be marked on the packaging?

e.g.
Sterile                                                                                                          Non sterile
x 10                                                                                                                x1
[picture of the device]                                                                            [picture of the accessory]


"appplicable for [device name] only"                                          no symbols for the acessory - because it is not a MD?
[Sterile symbol] [do not reuse] [MD symbols etc...]                           or... "applicable for [accessory] only"
                                                                                                                          [non sterile symbol] [etc...]


The space is limited and I want to avoid having to fit 10 translations of
"appplicable for [device name] only"
"applicable for [accessory] only"

Would this trigger the pack being considered a Procedure Pack under Article 22?


Thanks for your ideas :-)



------------------------------
Tom Morrison
Q&RA Officer
France
------------------------------

Hello Tom,

First it most likely would not be a procedure pack under Article 22.  The idea with procedure packs are these are different already CE Marked products put together in a kit for ease or convenience.  Not necessarily products which are just packaged together from the same manufacturer.  But unfortunately there is a lot of interpretation of Article 22, so maybe.

I have experience doing something similar where the label on the outside describes the products on the inside.  It does need some creative on how to ensure meeting regulatory requirements and conveying information to the user.  I had gone a few rounds with mostly Notified Body reviewers on content of labels because they had different views, interpretations, or how information is conveyed, e.g. having a Sterile symbol on the same label as a Non-Sterile symbol.  Generate the label from a user perspective if the information is understood and risks with confusion or not understanding what is single-use and what is re-use.  It also might not be an option but would be cleaner having a box for the sterile product, a box for the non-sterile adapter, which are both individually labelled, and then putting these in another larger box which has one or two other descriptive labels.  There can be different configurations used, the recommendation within your internal documentation clearly define the reason and justification for the approach.

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

Original Message:
Sent: 20-Apr-2022 10:49
From: thomas morrison
Subject: Labelling Advice - Nont sterile Reusable Accessory + sterile single use device

Hello,

We are based in the EU and are finishing the technical files for the MDR review.


We have a sterile single use device (Class IIa) sold in boxes of 10. This medical device does not require a notice.


In the box of 10, we put an accessory (a non sterile, resuable adaptor). It is OK for >10 reuses / sterilisation cycles. An IFU will go in the box to explain how to resterilise the adaptor.

Does anyone have any advice, how the two items should be marked on the packaging?

e.g.
Sterile                                                                                                          Non sterile
x 10                                                                                                                x1
[picture of the device]                                                                            [picture of the accessory]


"appplicable for [device name] only"                                          no symbols for the acessory - because it is not a MD?
[Sterile symbol] [do not reuse] [MD symbols etc...]                           or... "applicable for [accessory] only"
                                                                                                                          [non sterile symbol] [etc...]


The space is limited and I want to avoid having to fit 10 translations of
"appplicable for [device name] only"
"applicable for [accessory] only"

Would this trigger the pack being considered a Procedure Pack under Article 22?


Thanks for your ideas :-)



------------------------------
Tom Morrison
Q&RA Officer
France
------------------------------

I'm sorry, Richard, but you just can't ignore the MDR requirements when they are so plainly stated.

Article 22 states:

"Natural or legal persons shall draw up a statement if they 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 or procedure pack:
(a) other devices bearing the CE marking;"
etc

'Procedure pack' and 'system' are defined as follows:

"(10) 'procedure pack' means a combination of products packaged together and placed on the market with the purpose of being used for a specific medical purpose;
(11) 'system' means a combination of products, either packaged together or not, which are intended to be inter-connected or combined to achieve a specific medical purpose;"

From Tom's description of his assembly of two CE marked devices, it clearly falls into one or even both of these definitions, therefore Article 22 should apply.

------------------------------
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: 21-Apr-2022 05:33
From: Richard Vincins
Subject: Labelling Advice - Nont sterile Reusable Accessory + sterile single use device

Hello Tom,

First it most likely would not be a procedure pack under Article 22.  The idea with procedure packs are these are different already CE Marked products put together in a kit for ease or convenience.  Not necessarily products which are just packaged together from the same manufacturer.  But unfortunately there is a lot of interpretation of Article 22, so maybe.

I have experience doing something similar where the label on the outside describes the products on the inside.  It does need some creative on how to ensure meeting regulatory requirements and conveying information to the user.  I had gone a few rounds with mostly Notified Body reviewers on content of labels because they had different views, interpretations, or how information is conveyed, e.g. having a Sterile symbol on the same label as a Non-Sterile symbol.  Generate the label from a user perspective if the information is understood and risks with confusion or not understanding what is single-use and what is re-use.  It also might not be an option but would be cleaner having a box for the sterile product, a box for the non-sterile adapter, which are both individually labelled, and then putting these in another larger box which has one or two other descriptive labels.  There can be different configurations used, the recommendation within your internal documentation clearly define the reason and justification for the approach.

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

Original Message:
Sent: 20-Apr-2022 10:49
From: thomas morrison
Subject: Labelling Advice - Nont sterile Reusable Accessory + sterile single use device

Hello,

We are based in the EU and are finishing the technical files for the MDR review.


We have a sterile single use device (Class IIa) sold in boxes of 10. This medical device does not require a notice.


In the box of 10, we put an accessory (a non sterile, resuable adaptor). It is OK for >10 reuses / sterilisation cycles. An IFU will go in the box to explain how to resterilise the adaptor.

Does anyone have any advice, how the two items should be marked on the packaging?

e.g.
Sterile                                                                                                          Non sterile
x 10                                                                                                                x1
[picture of the device]                                                                            [picture of the accessory]


"appplicable for [device name] only"                                          no symbols for the acessory - because it is not a MD?
[Sterile symbol] [do not reuse] [MD symbols etc...]                           or... "applicable for [accessory] only"
                                                                                                                          [non sterile symbol] [etc...]


The space is limited and I want to avoid having to fit 10 translations of
"appplicable for [device name] only"
"applicable for [accessory] only"

Would this trigger the pack being considered a Procedure Pack under Article 22?


Thanks for your ideas :-)



------------------------------
Tom Morrison
Q&RA Officer
France
------------------------------

Hi 

Thanks for all your responses, I was not usure if it falls into the category of System / Procedure pack because the adaptors are an accessory, not a stand alone product, but having re-read the definitions and the MDCG, now it seems clear that the product is both a system and a procedure pack

I suppose, all this means is that we have to draw up a statement as per Article 22 (2). 

2.In the statement made pursuant to paragraph 1, the natural or legal person concerned shall declare that:
(a)they verified the mutual compatibility of the devices and, if applicable other products, in accordance with the manufacturers' instructions and have carried out their activities in accordance with those instructions;
(b) they packaged the system or procedure pack and supplied relevant information to users incorporating the information to be supplied by the manufacturers of the devices or other products which have been put together;
(c) the activity of combining devices and, if applicable, other products as a system or procedure pack was subject to appropriate methods of internal monitoring, verification and validation.


As for the Packaging, I'll just see what options the graphic designer can give us, and try to find a solution that is clear, maybe putting the adaptor and the associated information in a circle or square / using a different colour to seperate it. 

Kind regards
:-)



------------------------------
thomas morrison
Q&RA Officer
PARIS
France
------------------------------

Original Message:
Sent: 21-Apr-2022 05:59
From: Roger Gray
Subject: Labelling Advice - Nont sterile Reusable Accessory + sterile single use device

I'm sorry, Richard, but you just can't ignore the MDR requirements when they are so plainly stated.

Article 22 states:

"Natural or legal persons shall draw up a statement if they 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 or procedure pack:
(a) other devices bearing the CE marking;"
etc

'Procedure pack' and 'system' are defined as follows:

"(10) 'procedure pack' means a combination of products packaged together and placed on the market with the purpose of being used for a specific medical purpose;
(11) 'system' means a combination of products, either packaged together or not, which are intended to be inter-connected or combined to achieve a specific medical purpose;"

From Tom's description of his assembly of two CE marked devices, it clearly falls into one or even both of these definitions, therefore Article 22 should apply.

------------------------------
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: 21-Apr-2022 05:33
From: Richard Vincins
Subject: Labelling Advice - Nont sterile Reusable Accessory + sterile single use device

Hello Tom,

First it most likely would not be a procedure pack under Article 22.  The idea with procedure packs are these are different already CE Marked products put together in a kit for ease or convenience.  Not necessarily products which are just packaged together from the same manufacturer.  But unfortunately there is a lot of interpretation of Article 22, so maybe.

I have experience doing something similar where the label on the outside describes the products on the inside.  It does need some creative on how to ensure meeting regulatory requirements and conveying information to the user.  I had gone a few rounds with mostly Notified Body reviewers on content of labels because they had different views, interpretations, or how information is conveyed, e.g. having a Sterile symbol on the same label as a Non-Sterile symbol.  Generate the label from a user perspective if the information is understood and risks with confusion or not understanding what is single-use and what is re-use.  It also might not be an option but would be cleaner having a box for the sterile product, a box for the non-sterile adapter, which are both individually labelled, and then putting these in another larger box which has one or two other descriptive labels.  There can be different configurations used, the recommendation within your internal documentation clearly define the reason and justification for the approach.

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

Original Message:
Sent: 20-Apr-2022 10:49
From: thomas morrison
Subject: Labelling Advice - Nont sterile Reusable Accessory + sterile single use device

Hello,

We are based in the EU and are finishing the technical files for the MDR review.


We have a sterile single use device (Class IIa) sold in boxes of 10. This medical device does not require a notice.


In the box of 10, we put an accessory (a non sterile, resuable adaptor). It is OK for >10 reuses / sterilisation cycles. An IFU will go in the box to explain how to resterilise the adaptor.

Does anyone have any advice, how the two items should be marked on the packaging?

e.g.
Sterile                                                                                                          Non sterile
x 10                                                                                                                x1
[picture of the device]                                                                            [picture of the accessory]


"appplicable for [device name] only"                                          no symbols for the acessory - because it is not a MD?
[Sterile symbol] [do not reuse] [MD symbols etc...]                           or... "applicable for [accessory] only"
                                                                                                                          [non sterile symbol] [etc...]


The space is limited and I want to avoid having to fit 10 translations of
"appplicable for [device name] only"
"applicable for [accessory] only"

Would this trigger the pack being considered a Procedure Pack under Article 22?


Thanks for your ideas :-)



------------------------------
Tom Morrison
Q&RA Officer
France
------------------------------

Hello,

In fact I have spoken to my collegues, ad they have the same opinion as you Richard. 

We are the manufacturer of the CE marked device *and* the accessory.

I am just unsure if with having the Sterile Single Use device in the same "family" or technical file as the Non sterile Reusable accessory will be OK with the NB... only time will tell :-) 

Thanks for your advice about  looking at the labelling from the user perspective, and making sure the choices made are justified in the Technical File... that's really the key here.

Kind regards

------------------------------
thomas morrison
Q&RA Officer
PARIS
France
------------------------------

Original Message:
Sent: 21-Apr-2022 05:33
From: Richard Vincins
Subject: Labelling Advice - Nont sterile Reusable Accessory + sterile single use device

Hello Tom,

First it most likely would not be a procedure pack under Article 22.  The idea with procedure packs are these are different already CE Marked products put together in a kit for ease or convenience.  Not necessarily products which are just packaged together from the same manufacturer.  But unfortunately there is a lot of interpretation of Article 22, so maybe.

I have experience doing something similar where the label on the outside describes the products on the inside.  It does need some creative on how to ensure meeting regulatory requirements and conveying information to the user.  I had gone a few rounds with mostly Notified Body reviewers on content of labels because they had different views, interpretations, or how information is conveyed, e.g. having a Sterile symbol on the same label as a Non-Sterile symbol.  Generate the label from a user perspective if the information is understood and risks with confusion or not understanding what is single-use and what is re-use.  It also might not be an option but would be cleaner having a box for the sterile product, a box for the non-sterile adapter, which are both individually labelled, and then putting these in another larger box which has one or two other descriptive labels.  There can be different configurations used, the recommendation within your internal documentation clearly define the reason and justification for the approach.

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

Original Message:
Sent: 20-Apr-2022 10:49
From: thomas morrison
Subject: Labelling Advice - Nont sterile Reusable Accessory + sterile single use device

Hello,

We are based in the EU and are finishing the technical files for the MDR review.


We have a sterile single use device (Class IIa) sold in boxes of 10. This medical device does not require a notice.


In the box of 10, we put an accessory (a non sterile, resuable adaptor). It is OK for >10 reuses / sterilisation cycles. An IFU will go in the box to explain how to resterilise the adaptor.

Does anyone have any advice, how the two items should be marked on the packaging?

e.g.
Sterile                                                                                                          Non sterile
x 10                                                                                                                x1
[picture of the device]                                                                            [picture of the accessory]


"appplicable for [device name] only"                                          no symbols for the acessory - because it is not a MD?
[Sterile symbol] [do not reuse] [MD symbols etc...]                           or... "applicable for [accessory] only"
                                                                                                                          [non sterile symbol] [etc...]


The space is limited and I want to avoid having to fit 10 translations of
"appplicable for [device name] only"
"applicable for [accessory] only"

Would this trigger the pack being considered a Procedure Pack under Article 22?


Thanks for your ideas :-)



------------------------------
Tom Morrison
Q&RA Officer
France
------------------------------