Legislation for Healthcare, Medical Devices and In Vitro Diagnostic Medical Devices

Relevant EU legislation in the healthcare / medical devices sector referring to European and International standards. The main pieces of legislation referring to Harmonised Standards / European Standards for medical equipment/medical devices are:

Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC
Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU

Harmonised standards, Harmonized standards, EU Standards, EN Standards, CEN standards, Cenelec standards

Summary of references of Harmonised Standards in support of Regulation (EU) 2017/745 on Medical Devices - MDR

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 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) 2022/729 of 11 May 2022 amending Implementing Decision (EU) 2021/1195 as regards harmonised standards for quality management systems and for application of risk management to medical devices

Regulation (EU) 2017/746; IVDMDR; Harmonised standards; EU Standards for Medical Devices; EU Harmonised standards; In Vitro Diagnostic Medical Devices; Quality Management Systems for Medical Devices; Presumption of Conformity

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) 2022/757 of 11 May 2022 amending Implementing Decision (EU) 2021/1182 as regards harmonised standards for quality management systems, sterilisation and application of risk management to medical devices

Harmonised standards; MDR; Medical Devices Regulation; EN Standards; EU Standards; Presumption of conformity; harmonised standards

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

The EU's 2021/1195 Decision harmonizes standards for in vitro diagnostic devices, enhancing healthcare compliance and innovation.