Legislation for Healthcare and Medical Devices

Relevant legislation in the healthcare / medical devices sector referring to European and International standards

Summary of references in the Official Journal (as of 2022-01-07) in support of Regulation (EU) 2017/745 on Medical Devices

Summary of references to harmonised standards / consolidated list of harmonised standards under the Medical Devices Regulation (EU) 2017/745

Summary of references in the Official Journal (as of 2022-01-07) in support of Regulation (EU) 2017/746 on In Vitro Diagnostic Medical Devices

Summary of references to harmonised standards / consolidated list of harmonised standards under the In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746

Commission Implementing Decision (EU) 2022/15 of 6 January 2022 amending Implementing Decision (EU) 2021/1195 as regards harmonised standards for sterilisation of health care products, aseptic processing of health care products, quality MS, symbols, (...)

Harmonised standards providing presumption of conformity; Harmonized standards; Regulation (EU) 2017/746; in vitro diagnostic medical devices; IVDMD; IVD; CEN; CENELEC Standards; ISO standards; IEC standards; EC DG SANTE

Commission Implementing Decision 2022/6 amending Implementing Decision 2021/1182 on Harmonised Standards for biological evaluation of medical devices, sterilisation of health care products...

Regulation (EU) 2017/745; Harmonised standards providing presumption of conformity; Harmonized standards; Medical Devices Regulation; CEN; CENELEC Standards; ISO standards; IEC standards; EC DG SANTE

Commission Implementing Decision (EU) 2021/1182 of 16 July 2021 on the harmonised standards for medical devices drafted in support of Regulation (EU) 2017/745 of the European Parliament and of the Council

Harmonised standards providing presumption of conformity; Harmonized standards; Medical Devices Regulation; CEN; CENELEC Standards; EC DG SANTE; Regulation (EU) 2017/745;

Commission Implementing Decision (EU) 2021/1195 on the harmonised standards for in vitro diagnostic medical devices

Harmonised standards providing presumption of conformity; Harmonized standards; Regulation (EU) 2017/746; in vitro diagnostic medical devices; IVDMD; IVD; CEN; CENELEC Standards; ISO standards; IEC standards; EC DG SANTE