Standards and common specifications


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) 2024/2631 of 8 October 2024 amending Implementing Decision (EU) 2021/1182 as regards the harmonised standard for aseptic processing of health care products

OJ L, 2024/2631

(9th October 2024)

2024/3088

(13th December 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) 2024/2625 of 8 October 2024 amending Implementing Decision (EU) 2021/1195 as regards harmonised standards for aseptic processing of health care products and clinical performance studies using specimens from human subjects

OJ L, 2024/2625

(9th October 2024)

2024/3089

(13th December 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