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, find and download the harmonised standards for the MDR providing presumption of conformity

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

Find, obtain and download the 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;

Publication of references of Harmonised Standards for the In Vitro Diagnostics Medical Devices Regulation for for sterilization of medical devices - IVDMDR

10th of April 2025 Update: Find and Download the Harmonised Standards under the In Vitro Diagnostics Medical Devices Regulation (IVDMDR) Harmonized Standards MDR Standards providing presumption of conformity for sterilization of medical devices

Publication of references of Harmonised Standards for the MDR for medical gloves for single use, sterilization of medical devices and patient handling equipment

April 2025 Update : Download Harmonised Standards under the Medical Devices Regulation (MDR) Harmonized Standards MDR Standards presumption of conformity for medical gloves for single use, sterilization of medical devices and patient handling equipment

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.