Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Dear all,

I have a technical question regarding the soft transition after May 2020. Like anyone, our current MDD EC Certificate will be valid at most until its expiration date (2023 for us). Of course with the conditions included in MDR (e.g. no significant change, ...). And our EC Certificate (under annex V) explicitly lists (with product reference, REF) all of our products.

So here is my question. What will happen at the moment that we will transition existing devices (legacy devices) under the MDR? We will of course obtain a new MDR EC Certificate for the impacted devices. But, strictly speaking, this will mean that we will have 2 concurrent EC Certificate with the same product reference(s). We could imagine that our notified body should amend our current MDD EC Certificate to remove this/these product(s) however they should normally not issue / update any MDD EC Certificate after May 2020...

So what is the exact solution / regulatory path?
- Notified body are authorized to amend MDD EC Certificate to remove products (but I have seen nothing like this in the MDR)
- This is our internal responsibility to decide / document under which EC certificate and hence directive/regulation, we are selling our products. And here, this is the EC Declaration of Conformity that will describe this. Correct?
- something else that I have not think about ?

Thanks for your consideration on this technical question. I am sure that this applies to a lot of manufacturers.

You are asking a million dollar question that if you get an answer will receive one million dollars lol.  Unfortunately without getting clear direction from your Notified Body this is not really understood at this time how it may work because you are correct in thinking about transition some products without others.  The way current EC Certificates are written there may be a laundry list of products on a EC Certificate (under the MDD).  So lets take an example where a company has 5 products/product families and they are ready and want to transition two of those product families to EU MDR maybe for marketing purposes or competition.  What happens to the current EC Cert MDD that still has the other three listed, will there be a new EC Cert MDD issued?  Will they send a letter?  Will there be an amendment?  I have personally wondered how this will happen, but definitely should have this conversation with your Notified Body.

------------------------------
Richard Vincins RAC
Vice President Global Regulatory Affairs
------------------------------

Original Message:
Sent: 21-Jun-2019 06:18
From: Anonymous Member
Subject: MDR soft transition and EC Certificate(s)

This message was posted by a user wishing to remain anonymous

Dear all,

I have a technical question regarding the soft transition after May 2020. Like anyone, our current MDD EC Certificate will be valid at most until its expiration date (2023 for us). Of course with the conditions included in MDR (e.g. no significant change, ...). And our EC Certificate (under annex V) explicitly lists (with product reference, REF) all of our products.

So here is my question. What will happen at the moment that we will transition existing devices (legacy devices) under the MDR? We will of course obtain a new MDR EC Certificate for the impacted devices. But, strictly speaking, this will mean that we will have 2 concurrent EC Certificate with the same product reference(s). We could imagine that our notified body should amend our current MDD EC Certificate to remove this/these product(s) however they should normally not issue / update any MDD EC Certificate after May 2020...

So what is the exact solution / regulatory path?
- Notified body are authorized to amend MDD EC Certificate to remove products (but I have seen nothing like this in the MDR)
- This is our internal responsibility to decide / document under which EC certificate and hence directive/regulation, we are selling our products. And here, this is the EC Declaration of Conformity that will describe this. Correct?
- something else that I have not think about ?

Thanks for your consideration on this technical question. I am sure that this applies to a lot of manufacturers.

​According to TUV SUD, there is no issue having EC Certificates for MDD and MDR concurrently with the same product scope.  The DofC will call out which products are CE marked to which Directive/Regulation.  Of course, all products must transition to MDR before your MDD EC certificate expires.

------------------------------
Al Van Houdt RAC
Sr. Mgr. Regulatory Affairs & Compliance
Snoqualmie WA
United States
------------------------------

Original Message:
Sent: 21-Jun-2019 06:18
From: Anonymous Member
Subject: MDR soft transition and EC Certificate(s)

This message was posted by a user wishing to remain anonymous

Dear all,

I have a technical question regarding the soft transition after May 2020. Like anyone, our current MDD EC Certificate will be valid at most until its expiration date (2023 for us). Of course with the conditions included in MDR (e.g. no significant change, ...). And our EC Certificate (under annex V) explicitly lists (with product reference, REF) all of our products.

So here is my question. What will happen at the moment that we will transition existing devices (legacy devices) under the MDR? We will of course obtain a new MDR EC Certificate for the impacted devices. But, strictly speaking, this will mean that we will have 2 concurrent EC Certificate with the same product reference(s). We could imagine that our notified body should amend our current MDD EC Certificate to remove this/these product(s) however they should normally not issue / update any MDD EC Certificate after May 2020...

So what is the exact solution / regulatory path?
- Notified body are authorized to amend MDD EC Certificate to remove products (but I have seen nothing like this in the MDR)
- This is our internal responsibility to decide / document under which EC certificate and hence directive/regulation, we are selling our products. And here, this is the EC Declaration of Conformity that will describe this. Correct?
- something else that I have not think about ?

Thanks for your consideration on this technical question. I am sure that this applies to a lot of manufacturers.

For the same products or product groups you can have a MDD- as well as a MDR-Certificate the same time.

In addition, the Notified Body won´t be able and/or allowed to change any MDD-Certificate after May 2020, because there are NO MDD-Notified Bodies any more!

------------------------------
Klaus-Dieter Ziel, Managing Director
MEDCERT GmbH
Notified Body 0482
Hamburg, Germany
------------------------------

Original Message:
Sent: 24-Jun-2019 10:18
From: Al Van Houdt
Subject: MDR soft transition and EC Certificate(s)

​According to TUV SUD, there is no issue having EC Certificates for MDD and MDR concurrently with the same product scope.  The DofC will call out which products are CE marked to which Directive/Regulation.  Of course, all products must transition to MDR before your MDD EC certificate expires.

------------------------------
Al Van Houdt RAC
Sr. Mgr. Regulatory Affairs & Compliance
Snoqualmie WA
United States

Original Message:
Sent: 21-Jun-2019 06:18
From: Anonymous Member
Subject: MDR soft transition and EC Certificate(s)

This message was posted by a user wishing to remain anonymous

Dear all,

I have a technical question regarding the soft transition after May 2020. Like anyone, our current MDD EC Certificate will be valid at most until its expiration date (2023 for us). Of course with the conditions included in MDR (e.g. no significant change, ...). And our EC Certificate (under annex V) explicitly lists (with product reference, REF) all of our products.

So here is my question. What will happen at the moment that we will transition existing devices (legacy devices) under the MDR? We will of course obtain a new MDR EC Certificate for the impacted devices. But, strictly speaking, this will mean that we will have 2 concurrent EC Certificate with the same product reference(s). We could imagine that our notified body should amend our current MDD EC Certificate to remove this/these product(s) however they should normally not issue / update any MDD EC Certificate after May 2020...

So what is the exact solution / regulatory path?
- Notified body are authorized to amend MDD EC Certificate to remove products (but I have seen nothing like this in the MDR)
- This is our internal responsibility to decide / document under which EC certificate and hence directive/regulation, we are selling our products. And here, this is the EC Declaration of Conformity that will describe this. Correct?
- something else that I have not think about ?

Thanks for your consideration on this technical question. I am sure that this applies to a lot of manufacturers.