Standards

Harmonised European standards, published in the Official Journal of the European Union (OJEU)avautuu uuteen ikkunaan, facilitate compliance with the General Safety and Performance Requirements (GSPRs)avautuu uuteen ikkunaan set out in Regulation (EU) 2017/745 (MDR)avautuu uuteen ikkunaan and Regulation (EU) 2017/746 (IVDR)avautuu uuteen ikkunaan. These harmonised standards provide a presumption of conformity when applied correctly. For medical devices, relevant monographs from the European Pharmacopoeiaavautuu uuteen ikkunaan may also be used to support conformity where applicable.

While compliance with the GSPRs is mandatory, the use of harmonised standards remains voluntary. However, manufacturers often rely on them to streamline their conformity assessment procedures.

You can find a summary list of the titles and references of harmonised standards for medical devices published in the OJEU by following these links:

• For the Medical Devices Sector: https://health.ec.europa.eu/medical-devices-topics-interest/harmonised-standards_enavautuu uuteen ikkunaan
• For Internal Market, Industry, Entrepreneurship and SMEs: https://single-market-economy.ec.europa.eu/single-market/european-standards/harmonised-standards/medical-devices_enavautuu uuteen ikkunaan
• For In Vitro Diagnostic Medical Devices: https://single-market-economy.ec.europa.eu/single-market/european-standards/harmonised-standards/iv-diagnostic-medical-devices_enavautuu uuteen ikkunaan

Some of these standards are also applicable to sterile barrier systems (SBS). Companies in the SBS industry use the applicable harmonised standards to demonstrate that their products conform to the GSPRs of the MDR and, where relevant, the IVDR.

In particular, these standards include:

• EN ISO 11607-1:2020/A1:2023 – Packaging for terminally sterilized medical devices – Part 1: Requirements for materials, sterile barrier systems and packaging systems
• EN ISO 11607-2:2020/A1:2023 – Packaging for terminally sterilized medical devices – Part 2: Validation requirements for forming, sealing and assembly processes

CEN (the European Committee for Standardization) continues to play a central role in developing these standards. The CEN Technical Committee CEN/TC 102 is responsible for drafting standards that support the MDR and IVDR, particularly those related to sterilizers, washer-disinfectors, and associated accessories, helping ensure effective sterilization and maintenance of sterility.

For a complete list of standards developed by CEN/TC 102, visit the CEN Published Standardsavautuu uuteen ikkunaan.