The Complete Guide to Article 10a Compliance

In this Issue

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

From the Editor????

SAVE THE DATE: Join MedTech Leading Voice and MDG Premium for 10x 2025, Humanizing MedTech, May 6-7, in Newport Beach, CA.

?? Featured Posts: With the January 10th deadline to comply with Article 10a of EU MDR, we're featuring the new guide from AKRA TEAM, packed with insights and resources.

?? Plus 14 more super-useful new posts, Martin King’s Regulatory Roundup, and the latest 510(k) Clearances from Marcus Engineering, LLC.

Please complete the DeCODe Orphan Device Survey shared by Anneliene Jonker, supporting pediatric and orphan device development initiatives.

Featured Webinar

This webinar, featuring perspectives from top experts in the field—Matthias Fink?(AKRA TEAM),?Richard Holborow?(BSI), and?Nebojsa Serafimovic?(BASG/AGES)—offers an up-to-date overview of key considerations for manufacturers aiming to bring orphan devices to market or planning to include niche indications in their current labeling.

In Brief ??

In no special order...

• David Filmore highlighted the top 10 global medtech policy documents from 2024, curated from Market Pathways Document Depot.
• Scott Pantel discussed the growth trajectory of implantable devices and RPM markets, projected to peak by 2025.
• Michelle Lott, RAC explained FDA submission types, focusing on costs, timeframes, and key submission pathways.
• Tibor Zechmeister emphasized that MDR/IVDR are just the tip of the iceberg, listing six vital regulations MedTech firms must address.
• Barry Scannell explained why Recital 40 of the AI Act provides a significant exemption for Ireland from AI Act rules.
• Jose Bohorquez warned MedTech leaders about the broad FDA definition of “cyber devices,” emphasizing compliance strategies.
• Dr. Pallavi Dasgupta mapped the FDA transition from QSR to QMSR, focusing on regulatory impacts for manufacturers.
• Georg Digel outlined 8 common CAPA mistakes MedTech companies should avoid in 2025.
• Martin King shared the latest update of ISO Published Standards (Jan. 1, 2025).
• EU MDR Compliance shared 10 practical tips for post-market surveillance under MDR to streamline compliance.
• Marina Daineko highlighted the role of literature reviews in biological evaluations, referencing ISO 10993-1 Annex C.
• Brendan O'Leary presented a consolidated dataset from FDA decision summaries, providing key regulatory insights.
• Eric Henry discussed the FDA's draft guidance on AI-enabled device lifecycle management, clarifying marketing submissions.
• Darrin Carlson, RAC-Devices, PMP shared that 91% of FDA observations in 2023 were tied to the QSR.

Featured Post ??

Introducing the Complete Guide to Article 10a Compliance

As a follow-up to their recent Article 10a webinar, AKRA TEAM has launched EU MDR & IVDR Insider, a new free monthly publication for MedTech professionals.

The inaugural edition features The Complete Guide to Article 10a Compliance, packed with resources to help economic operators, Notified Bodies, and other stakeholders navigate this critical regulation. Inside, you’ll find a detailed decision tree, official resources, and four in-depth blog articles breaking down the implications of Article 10a.

Download your free guide.

Sections ?

Regulatory Roundup by Martin King - Week of January 6, 2025

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

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? 510(k)s at a Glance for the week of January 6, 2025

Marcus Engineering, LLC highlighted 35 new FDA 510(k) cleared devices last week, including 10 first-time clearances. ??

For full details, visit Marcus Engineering’s report.

??? What’s Happening

• Tuesday, Jan. 21 - Join Richard Holborow, Nebojsa Serafimovic, and Matthias Fink for a panel discussion on EU Orphan Devices. Register Now!
• Wednesday, Jan. 29 - MedTech C-BOM Masterclass - A Blueprint for FDA Medical Device Cryptography Compliance featuring Mark O. and Axel Wirth

Postscript ??

SAVE THE DATE: Join MedTech Leading Voice and MDG Premium for 10x 2025, Humanizing MedTech, May 6-7, in Newport Beach, CA.

- Sean ??