Understanding the Final EU AI Act

In this Issue

From the Editor ????| In-Brief?? |?Featured ???| Sections ? | Postscript ??

From the Editor????

The final EU ACT is here. Special thanks to Digital Bricks and KPMG for helping unpack it.

?? MHRA is moving the UK one step closer to international recognition of medical devices.

Plus, Martin King 's Regulatory Roundup and 10 more super-useful new posts you won't want to miss!

In Brief ??

• Digital Bricks summarized the first worldwide rules on AI
• MHRA announced an important framework for international recognition of medical devices
• Davide Saredi shared a useful report by KPMG on Decoding the EU AI Act?
• Andreas Stange overviewed important insights on MDR/IVDR progression
• An article written by Mukesh Kumar details the FDA and the acceptance of RWD
• Eric Henry has some questions about Epic’s release of an open-source AI validation tool for health systems
• A breakdown of Annex XVI and EU MDR, shared by Dr. Pallavi Dasgupta
• Key points from the FDA final guidance, shared by Charlyne Pereira
• Dr. med. Katharina Friedrich outlined the use of EHRs for post-market medical device data collection?
• Important UK regulatory news, shared by Jacqueline Beddoe-Rosendo
• Indre Semeskeviciute summarized a new revision guidance
• Post-approval changes to medical devices in Hong Kong, outlined by Mike Wetherington?
• An analysis phase report for MDR/IVDR and more, shared in Monday news by Marina Daineko

Sections ?

Featured ??

Press Release: MHRA Announces Proposed Framework for International Recognition of Medical Devices

Published: 21 May 2024

The Medicines and Healthcare products Regulatory Agency (MHRA) has announced a new initiative to recognize international regulatory approvals for medical devices. This proposed framework aims to enhance the regulatory environment in Great Britain by ensuring public health protection, fostering access to medical technology innovations, and maintaining an attractive market for the industry.

Key points from the announcement include:

• International Recognition: The MHRA intends to recognize regulatory approvals from Australia, Canada, the European Union, and the United States, depending on the device type, class, and prior approval. Discussions are ongoing with Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) for similar recognition.
• Reduction of Duplication: The framework aims to reduce duplicated assessments by leveraging comparable regulatory approvals, allowing resources to focus on innovative products that benefit patient health.
• Draft Framework: The proposed framework is still in draft form and will be integrated with future core regulations.
• Manufacturer Guidance: The announcement provides initial guidance to manufacturers on potential eligibility for alternative market routes under the new framework.

Dr. Laura Squire, the MHRA's Chief Quality and Access Officer, emphasized that this initiative is a significant step toward a robust MedTech regulatory framework that prioritizes patient safety, access to necessary medical devices, and the UK’s market attractiveness for medical technology innovators.

The MHRA remains committed to the UKCA marking for medical devices and continues to expand the capacity of UK Approved Bodies to support safe and early access to transformative medical products.

? Weekly Regulatory Roundup

By Martin King, May 20, 2024

In This Week's Regulatory Roundup

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Postscript ??

Stay tuned this week for a very special webinar announcement about (The last?) 10x Medical Device Conference

- Sean