Standards and common specifications

The list of titles of harmonized standards designated by Swissmedic can be found on the website of the Swiss Association for Standardisation (ASN):

• For medical devices (regulation (EU) 2017/745):
  https://www.switec.info/en/new-harmonised-standards/ > Medical Devices
• For in vitro diagnostic medical devices (regulation (EU) 2017/746):
  https://www.switec.info/en/new-harmonised-standards/ > In vitro diagnostic medical devices

Links to the list of harmonised standards from the EU Commission:

Harmonised standards according to Regulation (EU) 2017/745 on medical devices (MDR):

• 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
  
  
• COMMISSION IMPLEMENTING DECISION (EU) 2022/6 of 4 January 2022 amending Implementing Decision (EU) 2021/1182 as regards harmonised standards for biological evaluation of medical devices, sterilisation of health care products, aseptic processing of health care products, quality management systems, symbols to be used with information to be supplied by the manufacturer, processing of health care products and home light therapy 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 according to Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR):

• COMMISSION IMPLEMENTING DECISION (EU) 2021/1195 of 19 July 2021 on the harmonised standards for in vitro diagnostic medical devices drafted in support of Regulation (EU) 2017/746 of the European Parliament and of the Council
  
  
• 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 management systems, symbols to be used with information to be supplied by the manufacturer and requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples
  
  
• 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

• COMMISSION IMPLEMENTING REGULATION (EU) 2022/1107 of 4 July 2022 laying down common specifications for certain class D in vitro diagnostic medical devices in accordance with Regulation (EU) 2017/746 of the European Parliament and of the Council

Swissmedic cannot issue standards. Standards can be ordered here:

Swiss Association for Standardization (SNV)

• Swiss, European and other foreign standards
• Harmonised standards
• International standards
• Information material on standardisation

Swiss information and advice centre for standards and technical rules:

SWITEC

• Information on the Regulations (EU) 2017/745 on medical devices and (EU) 2017/746 on in vitro- diagnostic medical devices
• Information on the previous Medical Devices Directives 93/42/EEC, 90/385/EEC, 98/79/EC
• Information on conformity assessment
• Information on CE marking