Regulatory Open Forum

Dear all,

one of our distributors is applying to a tender, and he has problems being admitted due to issues with the declaration of conformity of the product (a set). We have authorization under MDD.
The problem is that an accessory that is part of the set and that is not CE marked is not listed in the declaration. Actually, on the declaration we have listed only the CE marked items that are part of the set, and not the others. Of course, all accessories are reported and evaluated in the TD for the device. 
It is a general issue that we have, for different clients and in different countries.

I have thought about a solution, that is, issuing another declaration of conformity listing as well the accessories. I have two problems with that:

1) In principle accessories have the same class as the parent device, even the ones that are not CE marked. If I put CE unmarked accessories as Class IIa, is this leading to the client looking for a label and CE mark on the unmarked accessory?
2) If I claim that unmarked accessory is class IIa, should I amend list of products on certificate of conformity of the company and thus involve the NB? (I think -hope- not)

I hope that the question make sense.

Thank you very much


------------------------------
Christian Micheletti
Project Manager; Regulatory Affairs expert
Zurich
Switzerland
------------------------------

Hi Christian,

If the 'accessory' is 'an accessory to a medical device' as defined in the MDD, then it has to be treated as if it is a medical device, and so will need to be CE marked, having undergone an appropriate conformity assessment procedure.

If it is not an 'accessory', as defined, then it is a non-medical product and does not belong on the DoC. Under these circumstances, however, if you are including this non-medical product in a kit or system, then you should follow guidance for MDD Article 12 for the combination of devices and non-devices, or I would suggest using the requirements of MDR Article 22 to produce a 'statement' that the components of the system are compatible, that relevant information on all system components has been supplied, and that the activity of combining the devices and other products has been subject to appropriate methods of internal monitoring, verification and validation.

You can then supply this statement alongside the DoC to show that MDD requirements have been met - hopefully this will be acceptable to the tendering authority.

------------------------------
Roger Gray
VP Quality and Regulatory
Donawa Lifescience Consulting
Clinical Studies - Regulatory - Quality Systems
Rome, Italy
+39 06 578 2665
rgray@donawa.com
www.donawa.com
------------------------------

Original Message:
Sent: 30-Nov-2020 09:15
From: Christian Micheletti
Subject: Declaration of conformity under MDD, accessories

Dear all,

one of our distributors is applying to a tender, and he has problems being admitted due to issues with the declaration of conformity of the product (a set). We have authorization under MDD.
The problem is that an accessory that is part of the set and that is not CE marked is not listed in the declaration. Actually, on the declaration we have listed only the CE marked items that are part of the set, and not the others. Of course, all accessories are reported and evaluated in the TD for the device.
It is a general issue that we have, for different clients and in different countries.

I have thought about a solution, that is, issuing another declaration of conformity listing as well the accessories. I have two problems with that:

1) In principle accessories have the same class as the parent device, even the ones that are not CE marked. If I put CE unmarked accessories as Class IIa, is this leading to the client looking for a label and CE mark on the unmarked accessory?
2) If I claim that unmarked accessory is class IIa, should I amend list of products on certificate of conformity of the company and thus involve the NB? (I think -hope- not)

I hope that the question make sense.

Thank you very much


------------------------------
Christian Micheletti
Project Manager; Regulatory Affairs expert
Zurich
Switzerland
------------------------------

Hi Christian, this is pretty complicated and does not have a simple answer.
First of all an accessory is only an accessory when it fulfills its definition in the MDD: 'an article which whilst not being a device is intended specifically by its manufacturer to be used together with a device to enable it to be used in accordance with the use of the device intended by the manufacturer of the device'.
The first question is whether your accessory is an accessory in the regulatory meaning?

if it is, then it is a medical device in its own right and has to be treated as such, including a DoC (its own or as accessory for the medical device it is meant for), its own CE mark and covered by a technical file confirming safety and performance (this again can be part of an overarching TF of the medical device for which the accessory is meant for). Such an accessory is also classified in its own right and does not per se follow the classification of the medical device for which the accessory is meant for. If the  classification leads to the involvement of a Notified Body, the accessory should be covered by a CE-certificate (again, can be part of the overarching CE certificate of he medical device for which the accessory is meant for).

You also say, the accessory is part of a product (set).That is not possible, because than it is not an accessory anymore, but it is a part of the product. It does not have its own CE mark, unless it is the main part of the product. the part still needs to be covered in the TF.

So if you want to market the 'part' as an accessory it first has to fulfill the definition of an accessory and secondly needs the coverage of a DoC and CE certificate (depending on its classification in its own right).

------------------------------
Peter Reijntjes
Principal Consultant Regulatory & Quality Affairs | Head of Training
Arnhem
Netherlands
------------------------------

Original Message:
Sent: 30-Nov-2020 09:15
From: Christian Micheletti
Subject: Declaration of conformity under MDD, accessories

Dear all,

one of our distributors is applying to a tender, and he has problems being admitted due to issues with the declaration of conformity of the product (a set). We have authorization under MDD.
The problem is that an accessory that is part of the set and that is not CE marked is not listed in the declaration. Actually, on the declaration we have listed only the CE marked items that are part of the set, and not the others. Of course, all accessories are reported and evaluated in the TD for the device.
It is a general issue that we have, for different clients and in different countries.

I have thought about a solution, that is, issuing another declaration of conformity listing as well the accessories. I have two problems with that:

1) In principle accessories have the same class as the parent device, even the ones that are not CE marked. If I put CE unmarked accessories as Class IIa, is this leading to the client looking for a label and CE mark on the unmarked accessory?
2) If I claim that unmarked accessory is class IIa, should I amend list of products on certificate of conformity of the company and thus involve the NB? (I think -hope- not)

I hope that the question make sense.

Thank you very much


------------------------------
Christian Micheletti
Project Manager; Regulatory Affairs expert
Zurich
Switzerland
------------------------------

Thank you for your answers, it was very helpful. At this point I know for sure that I need to involve my NB and agree with them a doable permanent solution.



------------------------------
Christian Micheletti
Project Manager; Regulatory Affairs expert
Zurich
Switzerland
------------------------------

Original Message:
Sent: 30-Nov-2020 09:15
From: Christian Micheletti
Subject: Declaration of conformity under MDD, accessories

Dear all,

one of our distributors is applying to a tender, and he has problems being admitted due to issues with the declaration of conformity of the product (a set). We have authorization under MDD.
The problem is that an accessory that is part of the set and that is not CE marked is not listed in the declaration. Actually, on the declaration we have listed only the CE marked items that are part of the set, and not the others. Of course, all accessories are reported and evaluated in the TD for the device.
It is a general issue that we have, for different clients and in different countries.

I have thought about a solution, that is, issuing another declaration of conformity listing as well the accessories. I have two problems with that:

1) In principle accessories have the same class as the parent device, even the ones that are not CE marked. If I put CE unmarked accessories as Class IIa, is this leading to the client looking for a label and CE mark on the unmarked accessory?
2) If I claim that unmarked accessory is class IIa, should I amend list of products on certificate of conformity of the company and thus involve the NB? (I think -hope- not)

I hope that the question make sense.

Thank you very much


------------------------------
Christian Micheletti
Project Manager; Regulatory Affairs expert
Zurich
Switzerland
------------------------------