Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

My view is that first 'treatment units' are not something that is in scope of article 22 MDR. Perhaps you mean procedure packs?
Secondly, what the sales department wants is irrelevant from a regulatory perspective and it would be quite risky to have your sales department determine regulatory matters and issue declarations with regulatory implications (like, in your example, apparently the article 22 MDR declaration), because that's not how a good QMS is supposed to work. I often see clients get themselves in trouble because they allow their sales departments to run with scissors the way your company is apparently willing to do. For example, they allow their sales department to call systems kits (confusing third parties such as the notified body and mislabeling them for example) and then are surprised that they run into enforcement by competent authorities or issues with their notified body because the company's marketing statements do not match the company's regulatory qualification of the product(s).
It is a determining factor for a system in the meaning of article 22 MDR that the system is placed on the market as such, which means that it is marketed and advertised and sold as such. This should be a given for the sales department. Sounds like some training is in order for your sales people and a QMS reorientation for the company that solidifies who's boss about regulatory matters. Pro tip: that should be the people that are qualified for regulatory matters. 
If you need help in understanding what a system is for the purposes of article 22 MDR, this is discussed in great detail in my book about the MDR and IVDR, the Enriched MDR and IVDR.

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Erik Vollebregt
Partner
Amsterdam
Netherlands
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Original Message:
Sent: 09-May-2023 03:54
From: Anonymous Member
Subject: MDR Article 22 - Definition of a "System"

This message was posted by a user wishing to remain anonymous

Hi Folks, 

 

I have a question which concerns me in connection with MDR Article 22 "Systems and treatment units". 

We are a manufacturer of medical devices for image processing in the field of endoscopy. However, we also purchase products on the market (commercial goods; medical devices but also non - medical devices such as network accessories, switches, routers, recording devices ... ) in order to bring them to the market together with products manufactured by us. 

 

My question refers to the first paragraph from Article 22 MDR:

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.

 

Currently, we are struggling to define when a combination of products should be considered a "system" in the sense of the MDR, or at which point the system boundaries should be drawn. From a regulatory point of view, the combination of products can be considered a system, but from the point of view of our sales department, they are independent products, not systems. Therefore, the sales department does not want to issue any corresponding declarations. 

 

What is your view on this? 

I am looking forward to a lively discussion!

 

'System' is a defined term in the MDR:
"(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;"

This should be sufficient to answer your question.

Roger Gray
Donawa Lifescience 
Rome, Italy

------------------------------
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: 09-May-2023 03:54
From: Anonymous Member
Subject: MDR Article 22 - Definition of a "System"

This message was posted by a user wishing to remain anonymous

Hi Folks, 

 

I have a question which concerns me in connection with MDR Article 22 "Systems and treatment units". 

We are a manufacturer of medical devices for image processing in the field of endoscopy. However, we also purchase products on the market (commercial goods; medical devices but also non - medical devices such as network accessories, switches, routers, recording devices ... ) in order to bring them to the market together with products manufactured by us. 

 

My question refers to the first paragraph from Article 22 MDR:

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.

 

Currently, we are struggling to define when a combination of products should be considered a "system" in the sense of the MDR, or at which point the system boundaries should be drawn. From a regulatory point of view, the combination of products can be considered a system, but from the point of view of our sales department, they are independent products, not systems. Therefore, the sales department does not want to issue any corresponding declarations. 

 

What is your view on this? 

I am looking forward to a lively discussion!

 

I'm not sure if these products as you state- "Non - Medical Devices Such As Network Accessories, Switches, Routers, Recording Devices ...)" are in line with Article 22 (c): 
"Other Products are in conformity with legislation that applies to those products only where they are used within and medical procedure or their presence in the system or procedure pack is otherwise justified"

This should also be considered in the overall context of the entire Article 22, and this consideration should be made by people, for example, from the Regulatory Affairs ,not people from Sales dpt., as Erik mentions it in his reaction.

------------------------------
Evangelos Tavandzis
Lead Auditor, Consultant
Praha
Czech Republic
------------------------------

Original Message:
Sent: 09-May-2023 03:54
From: Anonymous Member
Subject: MDR Article 22 - Definition of a "System"

This message was posted by a user wishing to remain anonymous

Hi Folks, 

 

I have a question which concerns me in connection with MDR Article 22 "Systems and treatment units". 

We are a manufacturer of medical devices for image processing in the field of endoscopy. However, we also purchase products on the market (commercial goods; medical devices but also non - medical devices such as network accessories, switches, routers, recording devices ... ) in order to bring them to the market together with products manufactured by us. 

 

My question refers to the first paragraph from Article 22 MDR:

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.

 

Currently, we are struggling to define when a combination of products should be considered a "system" in the sense of the MDR, or at which point the system boundaries should be drawn. From a regulatory point of view, the combination of products can be considered a system, but from the point of view of our sales department, they are independent products, not systems. Therefore, the sales department does not want to issue any corresponding declarations. 

 

What is your view on this? 

I am looking forward to a lively discussion!