Regulatory Open Forum

All,
The MDR timelines will be extended by the EU Commission. This is great news for all economic operators in our industry as well as clinicians and patients in the EU.

Here is the full draft proposal amend EU 2017/745 and EU 2017/746:
chrome-extension://efaidnbmnnnibpcajpcglclefindmkaj/https://data.consilium.europa.eu/doc/document/ST-15520-2022-INIT/en/pdf

I see one blind spot in the draft proposal. It does not address MDD certificates that have already expired since the MDR date of application.
Those manufacturers should also be granted the same extension (as long as they meet the other criteria).

The problem: current interpretation is that MDD legislation is no longer in force and notified bodies are no longer designated to issue CE certificates under MDD. A Notified Body would be unable to make any changes (including "reactivation") to MDD certificates.

Do you agree that recently expired MDD certificates should be granted the same extension as those about to expire? And why?

Thanks for your collaboration,

------------------------------
Rob Yamashita
Grand Rapids MI
United States
------------------------------

Hi Rob
It is assumed that it will be set up this way, but we will see in January, 2023 when the EU Commission prepares it.

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

Original Message:
Sent: 16-Dec-2022 09:15
From: Rob Yamashita
Subject: European Commission intend to extend date for EU MDR

All,
The MDR timelines will be extended by the EU Commission. This is great news for all economic operators in our industry as well as clinicians and patients in the EU.

Here is the full draft proposal amend EU 2017/745 and EU 2017/746:
chrome-extension://efaidnbmnnnibpcajpcglclefindmkaj/https://data.consilium.europa.eu/doc/document/ST-15520-2022-INIT/en/pdf

I see one blind spot in the draft proposal. It does not address MDD certificates that have already expired since the MDR date of application.
Those manufacturers should also be granted the same extension (as long as they meet the other criteria).

The problem: current interpretation is that MDD legislation is no longer in force and notified bodies are no longer designated to issue CE certificates under MDD. A Notified Body would be unable to make any changes (including "reactivation") to MDD certificates.

Do you agree that recently expired MDD certificates should be granted the same extension as those about to expire? And why?

Thanks for your collaboration,

------------------------------
Rob Yamashita
Grand Rapids MI
United States
------------------------------

Dear Rob

According to EC Health Dept meeting, which you can replay at the following link, the draft legislation will not be available till the 1st week of January.

Till 2023, we have no choice but to continue with our efforts, till the legal text has been approved by all relevant parties. Based on experience with this body, I do not expect a legal doc approved till Q2/ Q3 2023. 
https://video.consilium.europa.eu/event/en/26353

Let us hope that they draw up pragmatic legislation to extend the deadline for all devices - and not just legacy - till 2028 as well as make some needed changes in the legal requirements for CE marking through regulatory text and not MDCG (stated to be not legally binding). The MDR will not be touched but they can write legislation to overrule the existing text.
 

Best Regards,
Stephanie

------------------------------
Stephanie Grassmann
Founder & Managing Director of MedTechXperts Ltd
Biberstein
Switzerland
------------------------------

Original Message:
Sent: 16-Dec-2022 09:15
From: Rob Yamashita
Subject: European Commission intend to extend date for EU MDR

All,
The MDR timelines will be extended by the EU Commission. This is great news for all economic operators in our industry as well as clinicians and patients in the EU.

Here is the full draft proposal amend EU 2017/745 and EU 2017/746:
chrome-extension://efaidnbmnnnibpcajpcglclefindmkaj/https://data.consilium.europa.eu/doc/document/ST-15520-2022-INIT/en/pdf

I see one blind spot in the draft proposal. It does not address MDD certificates that have already expired since the MDR date of application.
Those manufacturers should also be granted the same extension (as long as they meet the other criteria).

The problem: current interpretation is that MDD legislation is no longer in force and notified bodies are no longer designated to issue CE certificates under MDD. A Notified Body would be unable to make any changes (including "reactivation") to MDD certificates.

Do you agree that recently expired MDD certificates should be granted the same extension as those about to expire? And why?

Thanks for your collaboration,

------------------------------
Rob Yamashita
Grand Rapids MI
United States
------------------------------