Our April MedTech news covers a round up of the latest updates and information from the EU Commission, MDCG, FDA, and NMPA. Read on for more.

In Global MedTech news

EU Commission proposes Regulation for European approach on AI

The EU Commission has proposed the first ever legal framework on Artificial Intelligence, which addresses the risks of AI, and positions Europe to play a leading role on the global stage.

The legislative proposal introduces a risk-based approach that distinguishes four risk categories spanning: unacceptable risk, high risk, limited risk and minimal risk. The proposal places the oversight responsibility with the national competent market surveillance authorities, with a European Artificial Intelligence Board facilitating the implementation of the Regulation and the development of AI standards. Find out more here.

FDA issues final rule on medical device classification regulations

The FDA has issued the final rule amending medical device classification regulations, excluding non-device software functions.

With this final rule, FDA is amending eight classification regulations to conform to the medical software provisions of the Cures Act and reflect the FDA’s current statutory authority. Find out more here.

China’s NMPA releases long awaited policy

The new China NMPA Reform “Regulation on the Supervision and Administration of Medical Devices” (or Order 739) has finally been released.

The long-awaited overarching policy becomes effective as of June 1, 2021. Compared with Order 680 released in May 2017, Order 739 formalises the responsibilities and accountabilities of Market Authorisation Holders (MAHs) for the complete product life cycle – balancing clinical needs and risks, encouraging innovation, and imposing heavier penalties on violations for both companies and their key individuals. Find out more here.

EU Commission updates Implementation Rolling Plan

The EU Commission has updated their Implementation Rolling Plan for Regulation (EU) 2017/745 and Regulation (EU) 2017/746.

Their rolling plan includes a list of identified essential implementing acts and other relevant initiatives that the Commission has adopted or intends to adopt in the future. Access the plan here.

Guidance news from the EU and China

MDCG releases guidance on standardisation for medical devices

The Medical Device Coordination Group (MDCG) has released guidance on standardisation for medical devices.

MDCG 2021-5 includes information on the EU legislation on medical devices within the “New Approach” and the “New Legislative Framework”, harmonised European standards, and the governance structure for standards in the medical devices sector. Read more here.

NMPA publishes guidelines for Device Master File (DMF) submissions

China’s NMPA has published guidelines for the voluntary record filing of a Device Master File (DMF) submission for domestic Class III and imported Class II and III medical devices and IVD reagents.

The DMF record filing procedure is focussed mainly on raw material supplier documentation and aims to avoid repeated submission and review of this technical data. Access the guidance document here to find out more about the DMF record filing requirements.

New Resources & Tools from the FDA

New CDRH Learn Modules now available

Following last month’s FDA workshops on How to Use Consensus Standards in Premarket Submissions, and The ASCA Pilot: Streamlining Conformity Assessment in Device Submissions, you can now view the webcasts on these new CDRH Learn Modules:

• Module 4: How to Use Consensus Standards in Premarket Submissions can be accessed here
• Module 5: The ASCA Pilot: Streamlining Conformity Assessment in Device Submissions can be accessed here

There are also new modules available for the MDSAP program. Find out more about the new Modules 1-9 here.

New information for Health Care Facilities: Reprocessing of Reusable Medical Devices

This month the FDA has updated their resource page on Reprocessing of Reusable Medical Devices.

The page provides links to guidelines, self-audit tools, education & training materials, and safety communications to help health care facilities establish, implement and improve their quality assurance programs related to reusable device reprocessing. Access the page here.

That concludes our April MedTech news. Check back in May for more updates.

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