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) 2026/193 of 28 January 2026 amending Implementing Decision (EU) 2021/1182 as regards harmonised standards for neurosurgical implants, biological evaluation of medical devices, clinical investigation of medical devices for human subjects, non-active surgical implants, sterilization of health care products, biocompatibility evaluation of breathing gas pathways in healthcare applications and small-bore connectors for liquids and gases in healthcare applications |
OJ L, 2026/193 (30th January 2026) |
2026/912 (13th April 2026) |
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) 2026/197 of 28 January 2026 amending Implementing Decision (EU) 2021/1195 as regards harmonised standards for sterilization of health care products and information supplied by the manufacturer (labelling) |
OJ L, 2026/197 (30th January 2026) |
2026/913 (13th April 2026) |
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