EU: First harmonised standards published for the MDR and IVDR

In mid-July, the EU published the first implementing decisions with harmonised standards regarding the regulation (EU) 2017/745 (MDR) and (EU) 2017/746 (IVDR) in the Official Journal. The lists currently contain five and four standards, respectively.

EN ISO 10993-23, which was newly published in 2021, on biocompatibility tests for irritation, as well as three standards relating to sterilisation procedures, and one standard relating to determining sterility, each in their most recent version, have been harmonised with the MDR. This list is identical apart from the biocompatibility standard for the IVDR.