Regulatory Open Forum

Friday should be "interesting"

Implementation of the Medical Device Regulation - Information from the Commission
Update regarding the state of play on the implementation of the Medical Device Regulations

https://data.consilium.europa.eu/doc/document/ST-15520-2022-INIT/en/pdf

------------------------------
Vineet Sarin PhD
President & CEO
Camarillo CA
United States
------------------------------

Indeed, I can not wait to hear what comes out of this meeting.  I wish it was televised :).  I can imagine there will be two outcomes possible (well variations of them): 1) nothing changes - its the industries fault for not being ready and prepared as they have continued to say or 2) they will implement a progressive roll-out based on classification of devices similarly as they did with the EU IVDR.  I could fully see where Class I sterile, reusable, and measuring devices may not have to be in conformity until 2028.  But for Class III devices (and maybe implants) can still see the May 2024 holding true.  I am waiting ...

------------------------------
Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs
------------------------------

Original Message:
Sent: 07-Dec-2022 17:27
From: Vineet Sarin
Subject: EU-MDR implementation

Friday should be "interesting"

Implementation of the Medical Device Regulation - Information from the Commission
Update regarding the state of play on the implementation of the Medical Device Regulations

https://data.consilium.europa.eu/doc/document/ST-15520-2022-INIT/en/pdf

------------------------------
Vineet Sarin PhD
President & CEO
Camarillo CA
United States
------------------------------

Dear Richard

There is streaming to the event live. 

Media advisory - Employment, Social Policy, Health and Consumer Affairs Council of 8 and 9 December 2022

 

Background information - possible proposals

https://data.consilium.europa.eu/doc/document/ST-15520-2022-INIT/en/pdf

Best Regards,
Stephanie


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

Original Message:
Sent: 08-Dec-2022 01:46
From: Richard Vincins
Subject: EU-MDR implementation

Indeed, I can not wait to hear what comes out of this meeting.  I wish it was televised :).  I can imagine there will be two outcomes possible (well variations of them): 1) nothing changes - its the industries fault for not being ready and prepared as they have continued to say or 2) they will implement a progressive roll-out based on classification of devices similarly as they did with the EU IVDR.  I could fully see where Class I sterile, reusable, and measuring devices may not have to be in conformity until 2028.  But for Class III devices (and maybe implants) can still see the May 2024 holding true.  I am waiting ...

------------------------------
Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs

Original Message:
Sent: 07-Dec-2022 17:27
From: Vineet Sarin
Subject: EU-MDR implementation

Friday should be "interesting"

Implementation of the Medical Device Regulation - Information from the Commission
Update regarding the state of play on the implementation of the Medical Device Regulations

https://data.consilium.europa.eu/doc/document/ST-15520-2022-INIT/en/pdf

------------------------------
Vineet Sarin PhD
President & CEO
Camarillo CA
United States
------------------------------

I watched the live stream, and it seemed like there was unanimous support for the shift in implementation deadline, but there were a couple countries who expressed concern about staggering the date by device classification as in the original proposal.  It also sounds like there could be a formal legislative proposal in January.

------------------------------
Steven Kachelmeyer RAC
VP Regulatory and Quality Affairs
Windermere FL
United States
------------------------------

Original Message:
Sent: 09-Dec-2022 03:13
From: Stephanie Grassmann
Subject: EU-MDR implementation

Dear Richard

There is streaming to the event live.

Media advisory - Employment, Social Policy, Health and Consumer Affairs Council of 8 and 9 December 2022

 

Background information - possible proposals

https://data.consilium.europa.eu/doc/document/ST-15520-2022-INIT/en/pdf

Best Regards,
Stephanie


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

Original Message:
Sent: 08-Dec-2022 01:46
From: Richard Vincins
Subject: EU-MDR implementation

Indeed, I can not wait to hear what comes out of this meeting.  I wish it was televised :).  I can imagine there will be two outcomes possible (well variations of them): 1) nothing changes - its the industries fault for not being ready and prepared as they have continued to say or 2) they will implement a progressive roll-out based on classification of devices similarly as they did with the EU IVDR.  I could fully see where Class I sterile, reusable, and measuring devices may not have to be in conformity until 2028.  But for Class III devices (and maybe implants) can still see the May 2024 holding true.  I am waiting ...

------------------------------
Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs

Original Message:
Sent: 07-Dec-2022 17:27
From: Vineet Sarin
Subject: EU-MDR implementation

Friday should be "interesting"

Implementation of the Medical Device Regulation - Information from the Commission
Update regarding the state of play on the implementation of the Medical Device Regulations

https://data.consilium.europa.eu/doc/document/ST-15520-2022-INIT/en/pdf

------------------------------
Vineet Sarin PhD
President & CEO
Camarillo CA
United States
------------------------------

I read that one of the proposals is to extend the transition period to allow companies to implement the new requirements. Personally, I would expect them to do that without drastic changes.

------------------------------
Olga Peycheva
Regulatory and Study Start Up Specialist
Solutions OP Ltd
olga.peycheva@solutionsop.co.uk
United Kingdom
------------------------------

Original Message:
Sent: 07-Dec-2022 17:27
From: Vineet Sarin
Subject: EU-MDR implementation

Friday should be "interesting"

Implementation of the Medical Device Regulation - Information from the Commission
Update regarding the state of play on the implementation of the Medical Device Regulations

https://data.consilium.europa.eu/doc/document/ST-15520-2022-INIT/en/pdf

------------------------------
Vineet Sarin PhD
President & CEO
Camarillo CA
United States
------------------------------

This message was posted by a user wishing to remain anonymous

First, Thank you for posting this information.

Second, I do not want to derail the conversation, but how are you staying aware of this information from the EC regarding MDR information? I have attempted different routes, one of the only useful ones is RSS feeds. I am a one man operation so any insight into how you are staying up to date on these items and being notified of these reports would be greatly appreciated.
Original Message:
Sent: 07-Dec-2022 17:27
From: Vineet Sarin
Subject: EU-MDR implementation

Friday should be "interesting"

Implementation of the Medical Device Regulation - Information from the Commission
Update regarding the state of play on the implementation of the Medical Device Regulations

https://data.consilium.europa.eu/doc/document/ST-15520-2022-INIT/en/pdf

------------------------------
Vineet Sarin PhD
President & CEO
Camarillo CA
United States
------------------------------

Sure thing.  I've been in this business for 20+ years so I have a lot of contacts (networking) and many newsletters / blog posts come to my email on a routine basis. This particular information was posted on LinkedIn by one of my contacts. I would recommend LinkedIn as a great source of information, especially if you establish connection with certain individuals who tend to be "in the know" on these types of topics. Good luck!

------------------------------
Vineet Sarin PhD
President & CEO
Camarillo CA
United States
------------------------------

Original Message:
Sent: 08-Dec-2022 11:35
From: Anonymous Member
Subject: EU-MDR implementation

This message was posted by a user wishing to remain anonymous

First, Thank you for posting this information.

Second, I do not want to derail the conversation, but how are you staying aware of this information from the EC regarding MDR information? I have attempted different routes, one of the only useful ones is RSS feeds. I am a one man operation so any insight into how you are staying up to date on these items and being notified of these reports would be greatly appreciated.
Original Message:
Sent: 07-Dec-2022 17:27
From: Vineet Sarin
Subject: EU-MDR implementation

Friday should be "interesting"

Implementation of the Medical Device Regulation - Information from the Commission
Update regarding the state of play on the implementation of the Medical Device Regulations

https://data.consilium.europa.eu/doc/document/ST-15520-2022-INIT/en/pdf

------------------------------
Vineet Sarin PhD
President & CEO
Camarillo CA
United States
------------------------------

Seconding LinkedIn as a good source. I do always look at bookmarked Commission sites, but LinkedIn almost always catches everything.

------------------------------
Corey Jaseph RAC
Senior Research Analyst
Wheatland CA
United States
------------------------------

Original Message:
Sent: 08-Dec-2022 11:35
From: Anonymous Member
Subject: EU-MDR implementation

This message was posted by a user wishing to remain anonymous

First, Thank you for posting this information.

Second, I do not want to derail the conversation, but how are you staying aware of this information from the EC regarding MDR information? I have attempted different routes, one of the only useful ones is RSS feeds. I am a one man operation so any insight into how you are staying up to date on these items and being notified of these reports would be greatly appreciated.
Original Message:
Sent: 07-Dec-2022 17:27
From: Vineet Sarin
Subject: EU-MDR implementation

Friday should be "interesting"

Implementation of the Medical Device Regulation - Information from the Commission
Update regarding the state of play on the implementation of the Medical Device Regulations

https://data.consilium.europa.eu/doc/document/ST-15520-2022-INIT/en/pdf

------------------------------
Vineet Sarin PhD
President & CEO
Camarillo CA
United States
------------------------------

I try to be positive through my day, but after watching this last Friday I was appalled, flabbergasted, and just shaking my head in disbelief and negativity.  The European Union really wants their activities in the Union to make people scratch their head in bewilderment.  No wonder places like Switzerland are now proposing legislation in their own country to use FDA market approvals and such instead of relying on CE Mark (and staying out of the ruckus of the EU).  There are groups which definitely saw the writing on the wall that products were no longer going to be available in Europe.

What shocks me is the regulation was published in 2017.  Until really end of 2019 into 2021 have they finally been working on things, but there are still, so so many questions.  And now we look at compliance dates of 2027 and 2028 ... 10 years after the regulation was published !  What I find appalling is Commission representatives sitting in public forums saying everything is on track (even up to mid-last year).  They should have used the last 5 years to get everything ready and then issue a compliance date when everything is actually ready - cough EUDAMED still not fully functional.

I still have two questions:
- What happens to all those companies which renewed their EU MDD Certificates till May 2024, what happens after 27 May 2024?  Do they get a "free" renewal period?
- What about the patients?  Has the European Union system become so legal and political they have lost sight of what medical devices and IVDs are for?

I could go on and on, but then it would be a book you have to read through haha !

------------------------------
Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs
------------------------------

Original Message:
Sent: 09-Dec-2022 14:07
From: Corey Jaseph
Subject: EU-MDR implementation

Seconding LinkedIn as a good source. I do always look at bookmarked Commission sites, but LinkedIn almost always catches everything.

------------------------------
Corey Jaseph RAC
Senior Research Analyst
Wheatland CA
United States

Original Message:
Sent: 08-Dec-2022 11:35
From: Anonymous Member
Subject: EU-MDR implementation

This message was posted by a user wishing to remain anonymous

First, Thank you for posting this information.

Second, I do not want to derail the conversation, but how are you staying aware of this information from the EC regarding MDR information? I have attempted different routes, one of the only useful ones is RSS feeds. I am a one man operation so any insight into how you are staying up to date on these items and being notified of these reports would be greatly appreciated.
Original Message:
Sent: 07-Dec-2022 17:27
From: Vineet Sarin
Subject: EU-MDR implementation

Friday should be "interesting"

Implementation of the Medical Device Regulation - Information from the Commission
Update regarding the state of play on the implementation of the Medical Device Regulations

https://data.consilium.europa.eu/doc/document/ST-15520-2022-INIT/en/pdf

------------------------------
Vineet Sarin PhD
President & CEO
Camarillo CA
United States
------------------------------

Fair points Richard, as someone working with an NB for almost 5 years (primarily IVD focus) the pace at which supporting infrastructure (EUDAMED, EURLs etc) coming on line has been disappointing, coupled with the pace of NB designations takes it from disappointing to frustration and beyond.

In relation to your questions - MDCG 2022-18 MDCG Position Paper on the application of Article 97 MDR to legacy devices for which the MDD or AIMDD certificate expires before the issuance of a MDR certificate - makes for some very interesting reading but had i such devices I'd be already sending emails to the relevant CA or getting your AR to do so.

------------------------------
Tom Patten
Dublin Dublin
Ireland
------------------------------

Original Message:
Sent: 12-Dec-2022 12:53
From: Richard Vincins
Subject: EU-MDR implementation

I try to be positive through my day, but after watching this last Friday I was appalled, flabbergasted, and just shaking my head in disbelief and negativity.  The European Union really wants their activities in the Union to make people scratch their head in bewilderment.  No wonder places like Switzerland are now proposing legislation in their own country to use FDA market approvals and such instead of relying on CE Mark (and staying out of the ruckus of the EU).  There are groups which definitely saw the writing on the wall that products were no longer going to be available in Europe.

What shocks me is the regulation was published in 2017.  Until really end of 2019 into 2021 have they finally been working on things, but there are still, so so many questions.  And now we look at compliance dates of 2027 and 2028 ... 10 years after the regulation was published !  What I find appalling is Commission representatives sitting in public forums saying everything is on track (even up to mid-last year).  They should have used the last 5 years to get everything ready and then issue a compliance date when everything is actually ready - cough EUDAMED still not fully functional.

I still have two questions:
- What happens to all those companies which renewed their EU MDD Certificates till May 2024, what happens after 27 May 2024?  Do they get a "free" renewal period?
- What about the patients?  Has the European Union system become so legal and political they have lost sight of what medical devices and IVDs are for?

I could go on and on, but then it would be a book you have to read through haha !

------------------------------
Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs

Original Message:
Sent: 09-Dec-2022 14:07
From: Corey Jaseph
Subject: EU-MDR implementation

Seconding LinkedIn as a good source. I do always look at bookmarked Commission sites, but LinkedIn almost always catches everything.

------------------------------
Corey Jaseph RAC
Senior Research Analyst
Wheatland CA
United States

Original Message:
Sent: 08-Dec-2022 11:35
From: Anonymous Member
Subject: EU-MDR implementation

This message was posted by a user wishing to remain anonymous

First, Thank you for posting this information.

Second, I do not want to derail the conversation, but how are you staying aware of this information from the EC regarding MDR information? I have attempted different routes, one of the only useful ones is RSS feeds. I am a one man operation so any insight into how you are staying up to date on these items and being notified of these reports would be greatly appreciated.
Original Message:
Sent: 07-Dec-2022 17:27
From: Vineet Sarin
Subject: EU-MDR implementation

Friday should be "interesting"

Implementation of the Medical Device Regulation - Information from the Commission
Update regarding the state of play on the implementation of the Medical Device Regulations

https://data.consilium.europa.eu/doc/document/ST-15520-2022-INIT/en/pdf

------------------------------
Vineet Sarin PhD
President & CEO
Camarillo CA
United States
------------------------------

Hi Tom,

Thank you for your words.  The problem persists: first the European Commission is just "passing the buck" onto the Competent Authorities to review MDD/AIMD certificates for expired products.  Which Competent Authority has those resources to review 15,000+ MDD certificates that are expiring in May 2024?  I would love to see IGZ, BfArM and others in the next year getting hundreds of notifications to 'proactively inform' them of non-compliance.  Second, again the Commission is a joke issuing "guidance" against articles, Article 94 and 97, which was never intended to be used for this reason.  Article 94 and 97 originated legally out of things like PIP and metal-metal implants to protect the public health and safety.  Not to be used as a stop-gap because the regulation was implemented so poorly by them.  Again it boggles me they write a "position paper" completely re-wording the regulation to fit their needs.  Apologise for the words, but I have a passion concerning this because until the Commission take responsibility or those with the ability to stop this madness, it will just continue now for years.  I wonder what medical device company will finally see CE Mark process as broken and say, "Let just sell products in the European Union without a CE Mark and deal with it afterwards."  As stated, the people being left out in this fiasco is patients who will not have access to perfectly high quality medical devices which have been on the market for 10+ years because the regulations have become so bureaucratic.  When the UK left the Union and Switzerland did not sign the MRA, I was thinking, 'What are they doing?' But now, I think they actually have the right idea.

------------------------------
Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs
------------------------------

Original Message:
Sent: 13-Dec-2022 06:11
From: Tom Patten
Subject: EU-MDR implementation

Fair points Richard, as someone working with an NB for almost 5 years (primarily IVD focus) the pace at which supporting infrastructure (EUDAMED, EURLs etc) coming on line has been disappointing, coupled with the pace of NB designations takes it from disappointing to frustration and beyond.

In relation to your questions - MDCG 2022-18 MDCG Position Paper on the application of Article 97 MDR to legacy devices for which the MDD or AIMDD certificate expires before the issuance of a MDR certificate - makes for some very interesting reading but had i such devices I'd be already sending emails to the relevant CA or getting your AR to do so.

------------------------------
Tom Patten
Dublin Dublin
Ireland

Original Message:
Sent: 12-Dec-2022 12:53
From: Richard Vincins
Subject: EU-MDR implementation

I try to be positive through my day, but after watching this last Friday I was appalled, flabbergasted, and just shaking my head in disbelief and negativity.  The European Union really wants their activities in the Union to make people scratch their head in bewilderment.  No wonder places like Switzerland are now proposing legislation in their own country to use FDA market approvals and such instead of relying on CE Mark (and staying out of the ruckus of the EU).  There are groups which definitely saw the writing on the wall that products were no longer going to be available in Europe.

What shocks me is the regulation was published in 2017.  Until really end of 2019 into 2021 have they finally been working on things, but there are still, so so many questions.  And now we look at compliance dates of 2027 and 2028 ... 10 years after the regulation was published !  What I find appalling is Commission representatives sitting in public forums saying everything is on track (even up to mid-last year).  They should have used the last 5 years to get everything ready and then issue a compliance date when everything is actually ready - cough EUDAMED still not fully functional.

I still have two questions:
- What happens to all those companies which renewed their EU MDD Certificates till May 2024, what happens after 27 May 2024?  Do they get a "free" renewal period?
- What about the patients?  Has the European Union system become so legal and political they have lost sight of what medical devices and IVDs are for?

I could go on and on, but then it would be a book you have to read through haha !

------------------------------
Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs

Original Message:
Sent: 09-Dec-2022 14:07
From: Corey Jaseph
Subject: EU-MDR implementation

Seconding LinkedIn as a good source. I do always look at bookmarked Commission sites, but LinkedIn almost always catches everything.

------------------------------
Corey Jaseph RAC
Senior Research Analyst
Wheatland CA
United States

Original Message:
Sent: 08-Dec-2022 11:35
From: Anonymous Member
Subject: EU-MDR implementation

This message was posted by a user wishing to remain anonymous

First, Thank you for posting this information.

Second, I do not want to derail the conversation, but how are you staying aware of this information from the EC regarding MDR information? I have attempted different routes, one of the only useful ones is RSS feeds. I am a one man operation so any insight into how you are staying up to date on these items and being notified of these reports would be greatly appreciated.
Original Message:
Sent: 07-Dec-2022 17:27
From: Vineet Sarin
Subject: EU-MDR implementation

Friday should be "interesting"

Implementation of the Medical Device Regulation - Information from the Commission
Update regarding the state of play on the implementation of the Medical Device Regulations

https://data.consilium.europa.eu/doc/document/ST-15520-2022-INIT/en/pdf

------------------------------
Vineet Sarin PhD
President & CEO
Camarillo CA
United States
------------------------------

This message was posted by a user wishing to remain anonymous

Richard-Thank you for getting the thoughts of many out on this thread. As someone green in the Regulatory world and trying to support my organization, it seems the message changes, the regulation is painfully tail-chasing circular, and makes less logic by the day. I appreciate your passion, and have stayed tuned for more information to come.
Original Message:
Sent: 13-Dec-2022 09:36
From: Richard Vincins
Subject: EU-MDR implementation

Hi Tom,

Thank you for your words.  The problem persists: first the European Commission is just "passing the buck" onto the Competent Authorities to review MDD/AIMD certificates for expired products.  Which Competent Authority has those resources to review 15,000+ MDD certificates that are expiring in May 2024?  I would love to see IGZ, BfArM and others in the next year getting hundreds of notifications to 'proactively inform' them of non-compliance.  Second, again the Commission is a joke issuing "guidance" against articles, Article 94 and 97, which was never intended to be used for this reason.  Article 94 and 97 originated legally out of things like PIP and metal-metal implants to protect the public health and safety.  Not to be used as a stop-gap because the regulation was implemented so poorly by them.  Again it boggles me they write a "position paper" completely re-wording the regulation to fit their needs.  Apologise for the words, but I have a passion concerning this because until the Commission take responsibility or those with the ability to stop this madness, it will just continue now for years.  I wonder what medical device company will finally see CE Mark process as broken and say, "Let just sell products in the European Union without a CE Mark and deal with it afterwards."  As stated, the people being left out in this fiasco is patients who will not have access to perfectly high quality medical devices which have been on the market for 10+ years because the regulations have become so bureaucratic.  When the UK left the Union and Switzerland did not sign the MRA, I was thinking, 'What are they doing?' But now, I think they actually have the right idea.

------------------------------
Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs

Original Message:
Sent: 13-Dec-2022 06:11
From: Tom Patten
Subject: EU-MDR implementation

Fair points Richard, as someone working with an NB for almost 5 years (primarily IVD focus) the pace at which supporting infrastructure (EUDAMED, EURLs etc) coming on line has been disappointing, coupled with the pace of NB designations takes it from disappointing to frustration and beyond.

In relation to your questions - MDCG 2022-18 MDCG Position Paper on the application of Article 97 MDR to legacy devices for which the MDD or AIMDD certificate expires before the issuance of a MDR certificate - makes for some very interesting reading but had i such devices I'd be already sending emails to the relevant CA or getting your AR to do so.

------------------------------
Tom Patten
Dublin Dublin
Ireland

Original Message:
Sent: 12-Dec-2022 12:53
From: Richard Vincins
Subject: EU-MDR implementation

I try to be positive through my day, but after watching this last Friday I was appalled, flabbergasted, and just shaking my head in disbelief and negativity.  The European Union really wants their activities in the Union to make people scratch their head in bewilderment.  No wonder places like Switzerland are now proposing legislation in their own country to use FDA market approvals and such instead of relying on CE Mark (and staying out of the ruckus of the EU).  There are groups which definitely saw the writing on the wall that products were no longer going to be available in Europe.

What shocks me is the regulation was published in 2017.  Until really end of 2019 into 2021 have they finally been working on things, but there are still, so so many questions.  And now we look at compliance dates of 2027 and 2028 ... 10 years after the regulation was published !  What I find appalling is Commission representatives sitting in public forums saying everything is on track (even up to mid-last year).  They should have used the last 5 years to get everything ready and then issue a compliance date when everything is actually ready - cough EUDAMED still not fully functional.

I still have two questions:
- What happens to all those companies which renewed their EU MDD Certificates till May 2024, what happens after 27 May 2024?  Do they get a "free" renewal period?
- What about the patients?  Has the European Union system become so legal and political they have lost sight of what medical devices and IVDs are for?

I could go on and on, but then it would be a book you have to read through haha !

------------------------------
Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs

Original Message:
Sent: 09-Dec-2022 14:07
From: Corey Jaseph
Subject: EU-MDR implementation

Seconding LinkedIn as a good source. I do always look at bookmarked Commission sites, but LinkedIn almost always catches everything.

------------------------------
Corey Jaseph RAC
Senior Research Analyst
Wheatland CA
United States

Original Message:
Sent: 08-Dec-2022 11:35
From: Anonymous Member
Subject: EU-MDR implementation

This message was posted by a user wishing to remain anonymous

First, Thank you for posting this information.

Second, I do not want to derail the conversation, but how are you staying aware of this information from the EC regarding MDR information? I have attempted different routes, one of the only useful ones is RSS feeds. I am a one man operation so any insight into how you are staying up to date on these items and being notified of these reports would be greatly appreciated.
Original Message:
Sent: 07-Dec-2022 17:27
From: Vineet Sarin
Subject: EU-MDR implementation

Friday should be "interesting"

Implementation of the Medical Device Regulation - Information from the Commission
Update regarding the state of play on the implementation of the Medical Device Regulations

https://data.consilium.europa.eu/doc/document/ST-15520-2022-INIT/en/pdf

------------------------------
Vineet Sarin PhD
President & CEO
Camarillo CA
United States
------------------------------

Richard, About the patients is exactly my main point. My CEO was asking me how this MDR situation would resolve itself. I said if nothing changes medical devices will begin to disappear for patients in the EU. There was no seeming logic to the changes and it felt like a "Let the market figure it out," except this was people's lives in the mix.


------------------------------
Edward Panek
VP, QA/RA
Med Device
USN Veteran
Research into Neural Nets - https://www.twitch.tv/edosani
------------------------------

Original Message:
Sent: 12-Dec-2022 12:53
From: Richard Vincins
Subject: EU-MDR implementation

I try to be positive through my day, but after watching this last Friday I was appalled, flabbergasted, and just shaking my head in disbelief and negativity.  The European Union really wants their activities in the Union to make people scratch their head in bewilderment.  No wonder places like Switzerland are now proposing legislation in their own country to use FDA market approvals and such instead of relying on CE Mark (and staying out of the ruckus of the EU).  There are groups which definitely saw the writing on the wall that products were no longer going to be available in Europe.

What shocks me is the regulation was published in 2017.  Until really end of 2019 into 2021 have they finally been working on things, but there are still, so so many questions.  And now we look at compliance dates of 2027 and 2028 ... 10 years after the regulation was published !  What I find appalling is Commission representatives sitting in public forums saying everything is on track (even up to mid-last year).  They should have used the last 5 years to get everything ready and then issue a compliance date when everything is actually ready - cough EUDAMED still not fully functional.

I still have two questions:
- What happens to all those companies which renewed their EU MDD Certificates till May 2024, what happens after 27 May 2024?  Do they get a "free" renewal period?
- What about the patients?  Has the European Union system become so legal and political they have lost sight of what medical devices and IVDs are for?

I could go on and on, but then it would be a book you have to read through haha !

------------------------------
Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs

Original Message:
Sent: 09-Dec-2022 14:07
From: Corey Jaseph
Subject: EU-MDR implementation

Seconding LinkedIn as a good source. I do always look at bookmarked Commission sites, but LinkedIn almost always catches everything.

------------------------------
Corey Jaseph RAC
Senior Research Analyst
Wheatland CA
United States

Original Message:
Sent: 08-Dec-2022 11:35
From: Anonymous Member
Subject: EU-MDR implementation

This message was posted by a user wishing to remain anonymous

First, Thank you for posting this information.

Second, I do not want to derail the conversation, but how are you staying aware of this information from the EC regarding MDR information? I have attempted different routes, one of the only useful ones is RSS feeds. I am a one man operation so any insight into how you are staying up to date on these items and being notified of these reports would be greatly appreciated.
Original Message:
Sent: 07-Dec-2022 17:27
From: Vineet Sarin
Subject: EU-MDR implementation

Friday should be "interesting"

Implementation of the Medical Device Regulation - Information from the Commission
Update regarding the state of play on the implementation of the Medical Device Regulations

https://data.consilium.europa.eu/doc/document/ST-15520-2022-INIT/en/pdf

------------------------------
Vineet Sarin PhD
President & CEO
Camarillo CA
United States
------------------------------

Dear All

Yes, Swissmedic must be relieved that Switzerland is not within the EU. EU Health have now transferred the workload and the responsibilities of legacy devices to the competent authorities (CA) based on a legally non-binding MDCG document. Last Friday, each speaker was given 1 minute to talk. Unanimously, extension was agreed but majority did not address issues with MDR and remedies. How could they with 1 minute granted. Claiming that the Ukraine war is associated as a main reason with the medical device shortages, reflects the state of affairs.
More individuals - not just healthcare providers and patients, etc - have now to suffer due to the contents of MDR and the inaction of the EC to act to repair the not-fit-to-purpose MDR (Monstrosity Device Regulation). 

Let us hope that the EC hangs around the punch bowl long enough in order that they listen to the real state of affairs in the EU and to hear the remedies required.

MDCG Document

https://health.ec.europa.eu/system/files/2022-12/mdcg_2022-18_en_0.pdf

Video to last Friday

https://video.consilium.europa.eu/event/en/26353

Wish all Happy Holidays! 


Best Regards,
Stephanie

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Stephanie Grassmann
Founder & Managing Director of MedTechXperts Ltd
Biberstein
Switzerland
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Original Message:
Sent: 07-Dec-2022 17:27
From: Vineet Sarin
Subject: EU-MDR implementation

Friday should be "interesting"

Implementation of the Medical Device Regulation - Information from the Commission
Update regarding the state of play on the implementation of the Medical Device Regulations

https://data.consilium.europa.eu/doc/document/ST-15520-2022-INIT/en/pdf

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Vineet Sarin PhD
President & CEO
Camarillo CA
United States
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