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):
Latest publications of the applicable designated technical standards:
Harmonised standards according to Regulation (EU) 2017/745 on medical devices (MDR):
Title |
Official Journal of the UE (publication date) |
Federal Gazette (publication date) |
COMMISSION IMPLEMENTING DECISION (EU) 2024/815 of 6 March 2024 amending Implementing Decision (EU) 2021/1182 as regards harmonised standards for medical gloves for single use, biological evaluation of medical devices, sterilization of health care products, packaging for terminally sterilized medical devices and processing of health care products |
OJ L, 2024/815 (8 March 2024) |
2024/865 (19 April 2024) |
Harmonised standards according to Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR):
Title |
Official Journal of the UE (publication date) |
Federal Gazette (publication date) |
COMMISSION IMPLEMENTING DECISION (EU) 2024/817 of 6 March 2024 amending Implementing Decision (EU) 2021/1195 as regards harmonised standards for sterilisation of health care products and packaging for terminally sterilised medical devices |
OJ L, 2024/817 (8 March 2024) |
2024/866 (19 April 2024) |
Publications of the applicable designated common specifications:
Title |
Official Journal of the UE (publication date) |
Federal Gazette (publication date) |
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 |
2022/L 178/3 (July 5, 2022) |
2022/3230 (December 30, 2022) |
COMMISSION IMPLEMENTING REGULATION (EU) 2022/2346 of 1 December 2022 laying down common specifications for the groups of products without an intended medical purpose listed in Annex XVI to Regulation (EU) 2017/745 of the European Parliament and of the Council on medical devices |
2022/L 311/60 (December 2, 2022) |
2023/2459 (November 1st, 2023) |
Swissmedic cannot issue standards. Standards can be ordered here:
- Swiss, European and other foreign standards
- Harmonised standards
- International standards
- Information material on standardisation
Swiss information and advice centre for standards and technical rules:
- 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