In one week, MDR 2017/745, dear to everyone’s heart, will enter into force. However, so that our MDD 93/42 MDs do not feel neglected, the European Commission has issued on April 14th, 2021, the latest list of harmonized standards to which these MDs will have to comply (EUR-Lex – 32021D0610 – EN – EUR-Lex (europa.eu)). On the same day, the Commission has published the list, validated by CEN and CENELEC, of standards to be harmonized for supporting compliance to MDR (https://ec.europa.eu/growth/tools-databases/mandates/index.cfm?fuseaction=search.detail&id=599).

 As such, ISO 20417: 2021, replacing EN 1041 under MDR, has been issued. Take the time to look at its Annex D. It is the 1st standard making the link with the general safety requirements. and clinical performance ((EU) 2017/745 and 2017/746).