New Regulation (UE) 2024/1860

Regulation (EU) 2024/1860, adopted by the European Parliament and the Council on June 13, 2024, aims to improve the market for medical devices and in vitro diagnostic devices while ensuring patient protection. This regulation brings significant changes to the existing regulations (EU) 2017/745 and (EU) 2017/746, particularly regarding the phased implementation of the European database Eudamed, notification obligations in case of supply interruptions, and transitional measures for certain devices.

Key Points

1. Eudamed:

• Eudamed is an essential database for ensuring transparency and traceability of medical devices in Europe. Although four of the seven planned electronic systems are already ready, the completion of the last two is expected in 2024.
• The system for clinical investigations and performance studies has been delayed due to its technical complexity.

2. Phased Implementation:

• The various electronic systems of Eudamed will be implemented progressively, as soon as their functionality is verified. This will reduce the administrative burden for manufacturers and health authorities.
• To avoid duplicate registrations in national databases and Eudamed, the application dates of the obligations will be harmonized.

3. Supply Interruption Notification:

• Manufacturers must notify authorities and their economic partners at least six months in advance in case of an interruption or cessation of supply of medical devices, if this may cause serious issues for patients or public health.
• This obligation includes explaining the reasons for the interruption or cessation.

4. Transitional Measures:

• To prevent shortages of in vitro diagnostic devices, the transitional periods for their certification are extended. This gives manufacturers and notified bodies the necessary time to complete conformity assessments.
• Devices covered by valid certificates under the old directive can continue to be marketed until the end of 2027 for class D devices and until the end of 2029 for class B devices.

Conclusion

Regulation (EU) 2024/1860 is designed to facilitate a smooth transition to the new regulations for medical devices and in vitro diagnostic devices, while preventing shortages and ensuring a high level of public health protection. The phased implementation of Eudamed and the new supply interruption notification obligations are essential elements to achieve these goals.

Link to the guide below. Enjoy 💕

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European Regulation for Medical Devices MDR 2017/745 have added new requested requirements and these requirements form part of the documentation to be presented to the notified body (e.g. review of the in-depth clinical evaluation, PMS procedure, QC results from validation products, proof of staff skills, etc.). CSDmed brings its expertise and a methodical approach to its clients, start-ups, manufacturers, importers and distributors of medical devices, thanks to a team of specialized experts and consultants, who will be able to address the MDR dossiers in their entirety.

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