MDR Revision: EU Parliament Calls for "Urgent need to revise the medical devices regulation"

In this Issue

From the Editor ????| In Brief ?? |?What's Happening ??? | Featured Interview ?? | Sections ? | Postscript ??

From the Editor????

Thanks to MedBoard and many others who shared last week's announcement from the European Parliament calling for a Urgent need to revise the medical devices regulation .

Live from Spain: In case you missed my live coverage of last week's RAPS European Clinical, Risk, and Postmarket Surveillance Conference in Barcelona.

?? Plus 15 more HOT new posts, Martin King ’s Regulatory Roundup, and the latest 510(k) Clearances from Marcus Engineering, LLC .

Join the RWE Symposium in Boston this Week!

In Brief ??

• ?? Trending Karandeep Singh Badwal (and Yoda) on meticulous documentation: If it’s not recorded, it didn’t happen.
• A CJEU ruling allowing GDPR breaches to be litigated through unfair competition law was analyzed by Cécile van der Heijden .
• Marco Caproni posted a list from IEC TC62 of standards for developing AI/ML in medical devices.
• Stefano Bolletta highlighted MDCG guidance on MDR requirements for legacy devices.
• The FDA’s new TPLC Advisory Program Pilot was and more was discussed by Marina Daineko .
• EU MDR Compliance detailed how to define your State Of The Art (SOTA) in a new infographic.
• A 28-step CAPA management cheat sheet by Georg Digel .
• Dr. Pallavi Dasgupta broke down the FDA Declaration of Conformity for Medical Devices?
• Yujan Shrestha, MD shared information on Microsoft’s new healthcare foundation models .
• The MDR changes creating the biggest stir were listed by Michelle Lott, RAC .
• A cheat-sheet for MedTech quality management models was posted by Bastian Krapinger-Ruether .
• Shaheen Gauher, PhD underscored the significance of responsible governance for AI/ML in the U.S.
• Robert Ruff reflected on the upcoming QMSR and how the FDA’s inspection approach may change .
• Mark Omo provided a medical device vulnerability checklist for security readiness.
• Key changes within the final draft of PMS Statutory Instrument were shared by Natasha Bankowski

Featured Update ??

Last week, MedBoard and others shared the European Parliament's urgent call to revise the Medical Devices Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR).

Here’s a summary of what they’re calling for:

• Immediate action by early 2025: Parliament wants the European Commission to fast-track regulatory updates to fix bottlenecks in MDR and IVDR.
• Support for Small and Medium Enterprises (SMEs): Simplify and reduce regulatory barriers that are blocking SMEs from certifying devices.
• More resources for notified bodies: Increase funding and capacity for these crucial bodies to meet growing certification demands and reduce delays.
• Clear, binding timelines: Set predictable timelines for certification steps, so manufacturers know how long the process will take.
• Transparent and fair fees: Create standardized fee structures so manufacturers can choose notified bodies without facing hidden costs.
• Cut down on re-certifications: Allow minor device updates without needing full re-certification, avoiding unnecessary delays.
• Prioritize innovative devices: Implement fast-track pathways for groundbreaking medical devices and those addressing urgent health needs.
• Include e-health applications: Ensure that all digital health devices meet safety standards, especially those handling sensitive health data.
• Support for orphan and pediatric devices: Tailor certification processes to meet the needs of niche markets like children’s devices and rare disease treatments.
• Track device availability through EUDAMED: Use the European Database on Medical Devices to monitor essential device availability and provide transparent info for healthcare providers and the public.

The European Parliament has made it clear: the current system needs urgent reform to keep healthcare devices safe, affordable, and accessible across the EU.

The next step? The European Commission has until early 2025 to start delivering these critical changes.

Sections ?

Regulatory Roundup by Martin King - Week of 21 October

Featuring the latest regulatory updates from : ?? ???????????????? ?????????????????????? ???????????????? ?????????????????? ?????????????? ???????????? ???????????????? ?????????????????? (??????), ???????????????????? ?????? (?????????????????????????? ???????????????????????? ?????? ??????????????????????????????)?? ???????????????????? ???? ???????????? ?????? ???????????? ?????????? ??????????????, ?????? ???????????????? ????????-???????????????? ?????????????? ???????????????? ????????????????????????????, ??.??. ???????????? ?????????????????????? ?????????????????????? ?????????? ???????????????????????????? (??????), ???????????????????? ?????? ???????? & ???????? ???????????????????????????? ???????? ?????????? ???????????? ???????????????????????? ??????.

Powered by Hoodin .

? 510(k)s at a Glance for the week of October 21, 2024

Marcus Engineering, LLC highlights 60 new FDA 510(k) cleared devices this week, including 22 first-time clearances ??. Featured categories include:

For full details, visit Marcus Engineering’s report.

??? What’s Happening

• RWE-Driven MedTech Symposium : October 29, 2024 – Boston, MA.
• Webinar on Structured Dialogue: The date and speakers will be announced soon!

Postscript ??

I had a wonderful time in Spain and look forward to Rome next month.

Sean ??