23/09/2024
Transitional provisions for the certification of Class D in vitro diagnostic (IVD) medical devices under the IVDR
The document MDCG 2021-4 Rev. 1, published by the Medical Device Coordination Group (MDCG), provides detailed guidelines on the transitional provisions for the certification of Class D in vitro diagnostic medical devices (IVDs) under Regulation (EU) 2017/746 (IVDR). Class D medical devices, being high-risk products, require a more complex conformity assessment process, involving expert panel consultations and participation of EU reference laboratories (EURL).
Izabela Chodara
Head of Clinical Unit | IVD