EU – two new MDCG guidelines published

The MDCG has published two new guidelines in the form of MDCG 2021-27 and MDCG 2021-28.

MDCG 2021-27 answers questions regarding the definition and obligations of importers and distributors as they are set out in Articles 13 and 14 of Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR).

MDCG 2021-28 deals with significant changes to clinical investigations as per the MDR. In this respect, the template linked in the guideline may be of particular interest; it can be used here until EUDAMED is fully available. However, the corresponding national provisions in the place of implementation must be observed.