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This message was posted by a user wishing to remain anonymous

Hi everyone,

Are companies still certifying to EU MDD 93/42/eec? Is there a deadline by which companies who wish to enter the EU market but are not ready for the MDR must certify to the MDD?  I have read that CE marks under the MDD will be valid for some time beyond the end of MDR transition, 2024.

Can somebody providing some insight into this and confirm my understanding? 

Thank you. 

This message was posted by a user wishing to remain anonymous

​Hello,
Yes, you can still CE mark your device under the MDD until May 2020, and assuming your device is not a "pure" class 1 device then you can theoretically receive a certificate that is valid until May 2024, as you mentioned. The big questions about when is the latest date that you can receive a certificate under MDD (design exam or Annex II QMS cert) really depends on the notified body you work with.
Some NBs have already announced a "cutoff" date after which they will no longer accept new submissions under MDD. Others are still willing to accept submissions for review. This is a business decision made by each NB depending on their work load and ability to assign reviewers to MDD certification requests. So you should check with your NB to see what their deadline is.

As for "pure" class 1 devices - those can only have a CE mark under MDD until May 2020. Once we reach that date you will have to self-certify those devices under MDR.

Hope this helps.
Original Message:
Sent: 13-Feb-2019 10:42
From: Anonymous Member
Subject: EU MDD audit

This message was posted by a user wishing to remain anonymous

Hi everyone,

Are companies still certifying to EU MDD 93/42/eec? Is there a deadline by which companies who wish to enter the EU market but are not ready for the MDR must certify to the MDD?  I have read that CE marks under the MDD will be valid for some time beyond the end of MDR transition, 2024.

Can somebody providing some insight into this and confirm my understanding?

Thank you.

Thanks. That's very helpful to know.  Is there a white paper or instructions from any of the NB's  that states that pure Class I device can only have a CE mark under MDD until May 2020? And why class I ?

------------------------------
Karen Zhou
------------------------------

Original Message:
Sent: 13-Feb-2019 15:53
From: Anonymous Member
Subject: EU MDD audit

This message was posted by a user wishing to remain anonymous

​Hello,
Yes, you can still CE mark your device under the MDD until May 2020, and assuming your device is not a "pure" class 1 device then you can theoretically receive a certificate that is valid until May 2024, as you mentioned. The big questions about when is the latest date that you can receive a certificate under MDD (design exam or Annex II QMS cert) really depends on the notified body you work with.
Some NBs have already announced a "cutoff" date after which they will no longer accept new submissions under MDD. Others are still willing to accept submissions for review. This is a business decision made by each NB depending on their work load and ability to assign reviewers to MDD certification requests. So you should check with your NB to see what their deadline is.

As for "pure" class 1 devices - those can only have a CE mark under MDD until May 2020. Once we reach that date you will have to self-certify those devices under MDR.

Hope this helps.
Original Message:
Sent: 13-Feb-2019 10:42
From: Anonymous Member
Subject: EU MDD audit

This message was posted by a user wishing to remain anonymous

Hi everyone,

Are companies still certifying to EU MDD 93/42/eec? Is there a deadline by which companies who wish to enter the EU market but are not ready for the MDR must certify to the MDD?  I have read that CE marks under the MDD will be valid for some time beyond the end of MDR transition, 2024.

Can somebody providing some insight into this and confirm my understanding?

Thank you.

This message was posted by a user wishing to remain anonymous

​I am not aware of a specific whitepaper, but basically the idea as I have interpreted it is that MDR date of application is May 2020 and so theoretically all devices should comply with MDR on that date. However, Article 120 (Transitional Provisions) allows certificates issued by a NB to continue to be valid for 5 years from the date of issuance and no later than May 2024.
Pure class 1 devices do not fall under a NB certificate and therefore my understanding is that they are not covered under the transitional provisions and must comply with MDR on the date of application.
Note point 4 in Article 120:
"Devices lawfully placed on the market pursuant to Directives 90/385/EEC and 93/42/EEC prior to 26 May 2020, and devices placed on the market from 26 May 2020 by virtue of a certificate as referred to in paragraph 2 of this Article, may continue to be made available on the market or put into service until 27 May 2025."
I believe this point further supports the interpretation that only devices which are covered under a NB certificate can continue to be placed on the market after May 2020.

Having said all this, I just want to also point out point 3 in Article 120, which talks about requirements for all devices past the date of application (May 2020):
"By way of derogation from Article 5 of this Regulation, a device with a certificate that was issued in accordance with Directive 90/385/EEC or Directive 93/42/EEC and which is valid by virtue of paragraph 2 of this Article may only be placed on the market or put into service provided that from the date of application of this Regulation it continues to comply with either of those Directives, and provided there are no significant changes in the design and intended purpose. However, the requirements of this Regulation relating to post-market surveillance, market surveillance, vigilance, registration of economic operators and of devices shall apply in place of the corresponding requirements in those Directives. "
So you should make sure that your company is prepared to follow these aspects of MDR starting May 2020 even if your devices are marked under MDD.
Original Message:
Sent: 13-Feb-2019 16:00
From: Karen Zhou
Subject: EU MDD audit

Thanks. That's very helpful to know.  Is there a white paper or instructions from any of the NB's  that states that pure Class I device can only have a CE mark under MDD until May 2020? And why class I ?

------------------------------
Karen Zhou

Original Message:
Sent: 13-Feb-2019 15:53
From: Anonymous Member
Subject: EU MDD audit

This message was posted by a user wishing to remain anonymous

​Hello,
Yes, you can still CE mark your device under the MDD until May 2020, and assuming your device is not a "pure" class 1 device then you can theoretically receive a certificate that is valid until May 2024, as you mentioned. The big questions about when is the latest date that you can receive a certificate under MDD (design exam or Annex II QMS cert) really depends on the notified body you work with.
Some NBs have already announced a "cutoff" date after which they will no longer accept new submissions under MDD. Others are still willing to accept submissions for review. This is a business decision made by each NB depending on their work load and ability to assign reviewers to MDD certification requests. So you should check with your NB to see what their deadline is.

As for "pure" class 1 devices - those can only have a CE mark under MDD until May 2020. Once we reach that date you will have to self-certify those devices under MDR.

Hope this helps.
Original Message:
Sent: 13-Feb-2019 10:42
From: Anonymous Member
Subject: EU MDD audit

This message was posted by a user wishing to remain anonymous

Hi everyone,

Are companies still certifying to EU MDD 93/42/eec? Is there a deadline by which companies who wish to enter the EU market but are not ready for the MDR must certify to the MDD?  I have read that CE marks under the MDD will be valid for some time beyond the end of MDR transition, 2024.

Can somebody providing some insight into this and confirm my understanding?

Thank you.