EU Commission Updates Harmonized Standards for In Vitro Devices

The Commission of the European Union (EU) has updated its list of harmonized standards applicable to in-vitro medical devices to reflect the latest available technical and scientific information.

According to Commission Implementing Decision (EU) 2021/1195, two new standards can now be used to demonstrate compliance with applicable requirements of the EU’s In Vitro Diagnostic Device Regulation, (EU) 2017/745. These are:

  • EN ISO 11737-2:2020, “Sterilization of health care products – Microbiological methods – Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process (ISO 11737-2:2019)”
  • EN ISO 25424:2019, “Sterilization of health care products – Low temperature steam and formaldehyde – Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 25424:2018)”

In addition, the Commission’s Implementing Decision designated amendments to current harmonized standards, as follows:

  • EN ISO 11135:2014/A1:2019, amendment to “Sterilization of health care products – Ethylene oxide – Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 11135:2014)”
  • EN ISO 11137-1:2015/A2:2019, amendment to “Sterilization of healthcare products – Radiation – Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11137-1: 2006, including Amd 1: 2013)”

Under Commission rules, compliance with an EU harmonized standard confers a presumption of conformity with the corresponding essential requirements in EU harmonization legislation once the standard has been published in the Official Journal of the European Union.

Read the text of the Commission’s Implementing Decision updating its list of harmonized standards for in vitro devices as published in the Official Journal.

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