New MDCG Guidance documents released

On December 12th, 2023, the Medical Device Coordination Group (MDCG) released the first revision on the Q&A regarding clinical investigations of devices conducted within the scope of the Regulation (EU) 2017/745 (MDR) (MDCG 2021-06 Revision 1).

MDCG 2021-06 Rev. 1: Regulation (EU) 2017/745 – Questions & Answers regarding clinical investigation

This revision contains important updates including 19 new entries, 11 revised entries and a new Annex.

This update includes amongst others a brand-new section on the role of the legal representative and it’s responsibilities (Q48-49-50) and a new interesting flowchart to help you decide if your combination product study requires an MDR clinical investigation submission (Annex III).

What does this mean to you?

MDCG 2021-06 Rev. 1 is of importance to all medical device manufacturers that are involved in clinical investigations but also provides important insights on the position of the European commission on the role of legal representative for IVD manufacturers.

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