Dear Reader

Please find below the latest news related to medical devices in Europe.

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The European Commission granting more transition time for certain IVD devices:

The European Commission welcomes granting more transition time from the current directive to the new EU IVDR Regulation for certain IVD devices:

• High individual and public health risk devices such as HIV or hepatitis tests (class D) will have a transition period until December 2027.
• High individual and/or moderate public health risk devices such as cancer tests (class C) will have a transition period until December 2028.
• Lower-risk devices (class B) such as pregnancy tests and (class A) sterile devices such as blood collection tubes have a transition period until December 2029.

The next steps include the formal adoption of the amending Regulation by the Council, which will enter into force on the day of its publication in the Official Journal of the European Union.

​Link to document​

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IMDRF document updates:

The IMDRF has updated several documents.

• Competence, Training, and Conduct Requirements for Regulatory Reviewers - IMDRF/GRRP WG/N40 FINAL:2024 (Edition 2)​

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• Essential Principles of Safety and Performance of Medical Devices and IVD Medical Devices - IMDRF/GRRP WG/N47 FINAL:2024 (Edition 2)​

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• Principles of Labeling for Medical Devices and IVD Medical Devices - IMDRF/GRRP WG/N52 FINAL:2024 (Edition 2)​

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• Requirements for Regulatory Authority Recognition of Conformity Assessment Bodies Conducting Medical Device Regulatory Reviews - IMDRF/GRRP WG/N59 FINAL:2024 (Edition 2)​

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• Regulatory Authority Assessment Method for Recognition and Surveillance of Conformity Assessment Bodies Conducting Medical Device Regulatory Reviews - IMDRF/GRRP WG/N61 FINAL:2024 (Edition 2)​

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• Competence and Training Requirements for Regulatory Authority Assessors of Conformity Assessment Bodies Conducting Medical Device Regulatory Reviews - IMDRF/GRRP WG/N63 FINAL:2024 (Edition 2)​

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• Assessment and Decision Process for the Recognition of a Conformity Assessment Body Conducting Medical Device Regulatory Reviews - IMDRF/GRRP WG/N66 FINAL:2024 (Edition 2)​

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• Medical Device Regulatory Review Report: Guidance Regarding Information to be Included - IMDRF/GRRP WG/N71 FINAL:2024 (Edition 2)​

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Your Regulatory Globe Team

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