Thank you for your comments back. I appreciate and value your opinion.
I have been in conversation with the big companies. They have also not succeeded.
Yes, I agree with you. We have had Brexit. I assume that we will have Medexit in which countries will ignore the medical device regulation.
Issues are not isolated to only MDR but to other EU regulatory frameworks.
Let us not forget UK has left and Switzerland has not joined.
Some EU countries are silently doing their own things. We have a few examples presented in the forum.
Original Message:
Sent: 01-Dec-2023 02:51
From: Richard Vincins
Subject: France raising MDR/ IVDR concern at EPSCO (Health) in Brussels 30th Nov 2023
Hello,
I think most of you know my opinion on the current state of the European Union in regards to medical devices and IVD medical devices from my posts. Rather than bog down in politics and bureaucracy, the European Union Commission should follow their own mandates and protect citizens of the European Union. The current actions are going to leave many citizens with limited to no viable health care options and no access to latest technology. This is just as bad as allowing failing products to enter the market. Companies are not able to move to EU MDR compliance because they are still dealing with all the incompetencies of renewing/updating their EU MDD compliance. Shocks and horrifies me every single time I see audit lists and review lists - creating 1000 more pages of documents is not going to make a product safer which has already been on the market 14 years.
There are many things which can be done and improved even beyond the position paper published already last year with no meaningful improvements. Notified Body system needs to be flat fee and completely transparent - not a business model for profit. Products with known safety and performance profiles should be accepted as such. Remove the barriers to market for innovative products or provide alternate pathways for innovative products. IT infrastructure needs to be put in place now. I could continue ...
Sorry Stephanie though I disagree that we can help to change the environment. I can not make it change. You can not make it change. Small companies can not make it change. Large companies can make it change. Competent Authorities can make it change. If sufficient large companies support the entire industry, they can say "Enough is enough," and disrupt the system. Because at some point even those large companies will struggle getting their new and innovative products to market in the EU. If I was responsible for the health and welfare of my citizens at a Competent Authority or National Health Ministry, I would leave the European Union also to ensure my citizens had proper access to medical device and IVD medical devices. Disrupt the system so true and effective change can be made to this blundering, disastrous, and appalling situation which is happening now.
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Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs
Oriel STAT A MATRIX - ENTERPRISE
Original Message:
Sent: 01-Dec-2023 01:34
From: Stephanie Grassmann
Subject: France raising MDR/ IVDR concern at EPSCO (Health) in Brussels 30th Nov 2023
Dear Julie, Dan, Armin, Ed
Thank you all for contributing to the discussion.
We need everyone's help to change the political environment and medical device submission process in EU as well as Switzerland (chosen to follow most of MDR).
Julie, I fully agree with you as well as previous points made by the other contributors.
Safer products are realised not by creating 5x as much documentation for market submission.
The real safety and effectiveness is known from the tracking of medical device from the timepoints of market entry - a point that FDA has realised with their initiatives of collecting real world data and real world evidence.
Technical Files and Clinical Evaluation Reports either written for the competent authorities (MD Class I) or submitted to the notified bodies for MDR CE certification are ideal representations of the data and information associated with the medical device with clinical data derived from the perfect patient group.
I am extremely concerned, as a veteran participant/ worker in the medical device industry (researcher started in medical devices in early 1990s) and having co-workers, friends and family highly dependant on receiving medical devices and medical care.
We all need to come together and find solutions immediately.
Some solutions, I have posted on my LinkedIn page. Please support us.
https://www.linkedin.com/feed/update/urn:li:activity:7135912114619039744/
Best Regards,
Stephanie
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Stephanie Grassmann
Founder & Managing Director of MedTechXperts Ltd
Biberstein
Switzerland
Original Message:
Sent: 30-Nov-2023 18:10
From: Julie Broderick
Subject: France raising MDR/ IVDR concern at EPSCO (Health) in Brussels 30th Nov 2023
Thanks for this interesting discussion.
I am a regulatory consultant and primarily work with start-ups. Ten years ago they would all have come to me asking to go to the EU first. Now they are all going US first, and no one is even considering approaching the EU market and CE marking under the MDR.
In addition, many companies with legacy devices are opting out of the EU market, unless the revenue from their products more than justifies the expense and time to obtain a CE mark under the MDR. It's not that these companies are lazy or unmotivated to apply for a MDR CE mark. They have made a business decision that the EU market doesn't justify the investment.
I wonder how long it will take the EU Commission to figure out that they have swung the pendulum way too far in the direction of over-regulation. The increased testing, clinical data requirements and number of documents, as well as the frequency of updates, especially for class IIb and III devices, is overwhelming for all but the biggest medical device manufacturers. I find it hard to believe that medical devices will be substantially safer or more effective after all this work is done.
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Julie Broderick RAC
Principal/Consultant
Winchester MA
United States
Original Message:
Sent: 30-Nov-2023 10:36
From: Dan O'Leary
Subject: France raising MDR/ IVDR concern at EPSCO (Health) in Brussels 30th Nov 2023
I have been concerned about the problems raised here. Basically that device manufacturers will abandon the EU leaving a shortage of some devices and a consolidation to only larger manufacturers.
One of the goals of the new regulations was to improve devices so the people of the EU have access to best devices in the world. It appears the method was to increase the scope and depth of the regulatory requirements while eliminating "poor performing" NBs.
I wonder, I've not seen any analysis, how often device manufacturers change or redesign an MDD device because it does not meet the MDR requirements. Basically the question is how often does the MDR cause improved devices over the MDD counterpart.
I suspect this improvement case is rare and MDR devices are actually MDD devices with more and different documentation.
Does anybody have insight into this issue?<o:p></o:p>
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Dan O'Leary CQA, CQE
Swanzey NH
United States
Original Message:
Sent: 30-Nov-2023 07:26
From: Stephanie Grassmann
Subject: France raising MDR/ IVDR concern at EPSCO (Health) in Brussels 30th Nov 2023
France raising MDR/ IVDR concern at EPSCO (Health) in Brussels 30th Nov 2023.
https://data.consilium.europa.eu/doc/document/ST-15385-2023-INIT/x/pdf
Video of Today, see start at 12:51. France is not alone as you see in the video.
https://video.consilium.europa.eu/event/en/27198
LinkedIn Post
https://www.linkedin.com/feed/update/urn:li:activity:7135912114619039744/
1217 MDR CE certificates total with flattening MDR CE certification application curve with only 4106 applications total for MDR CE certification to date according to MDCG (see link)
https://health.ec.europa.eu/system/files/2023-11/mdcg_2022-11_en.pdf
Medical device & IVD shortages in 2024 and onwards in Europe if nothing changes, I would expect.
Best Regards,
Stephanie
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Stephanie Grassmann
Founder & Managing Director of MedTechXperts Ltd
Biberstein
Switzerland
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