New MDCG Documents on Medical Device Regulation Released

The Medical Device Coordination Group (MDCG) has issued new guidelines for the implementation of the Medical Device Regulation (MDR). Here is a summary of the key documents:

• MDCG 2024-10 (June 2024): This guideline addresses the clinical evaluation of medical devices for rare diseases. It complements other guidelines on clinical trials and excludes custom-made devices and in vitro diagnostics.
• MDCG 2022-13 Rev.1 (June 2024): Addressed to authorities responsible for designating notified bodies, with no direct relevance for manufacturers.
• MDCG 2022-4 Rev. 2 (May 2024): This guideline covers transitional provisions for certain medical devices under Article 120 of the MDR. Products with valid certificates according to the MDD or AIMDD may be placed on the market or put into service under certain conditions until the end of 2027 or 2028. Continuous monitoring by a notified body is required
• MDCG 2024-6 and MDCG 2024-7 (May 2024): These documents provide templates for preliminary assessments by notified bodies.
• MDCG 2024-5 and MDCG 2024-3 (April and March 2024): These guidelines assist sponsors in preparing the “Investigator’s Brochure” and the “Clinical Investigation Plan.” They provide detailed instructions on the required contents.

These new documents offer important guidance for complying with the MDR and support manufacturers and authorities in implementing the new regulations.