EU commission implementing decision on harmonised standards for medical devices drafted in support of the MDR published

The Commission Implementing Decision (EU) 2021/1182 of 16 July 2021 on the harmonised standards for medical devices drafted in support of Medical Devices Regulation (EU) 2017/745 (MDR) of the European Parliament and of the Council has been published.

About commission Implementing decisions

A commission implementing decision is a legally binding act of the European Union directly applicable in all member states of the EU.

Implementing decisions:

  • can address specific legal entities, in which case it is binding only to them
  • are always limited in scope. Their aim is to ensure uniform implementation of European legislation, and the subject-matter of any implementing decision serves that goal alone
  • are directly applicable and need not be transposed into national legislation
  • take precedence over national legislation in case the two contradict one another
  • can only be issued when European legislation stipulates further measures are called for to ensure proper (and often uniform) implementation of said legislation by the member states
  • deal with very specific issues and often address highly technical details of legislation. Often, implementing decisions address specific legal entities.
Article 8 of the MDR

In accordance with Article 8 of Medical Devices Regulation (EU) 2017/745 of the European Parliament and of the Council , devices that are in conformity with the relevant harmonised standards, or the relevant parts of those standards, the references of which have been published in the Official Journal of the European Union, are to be presumed to be in conformity with the requirements of that Regulation covered by those standards or parts thereof.

References of harmonised standards

The references of harmonised standards for medical devices drafted in support of Medcal Devices Regulation (EU) 2017/745 and listed in the Annex to this Decision are hereby published in the Official Journal of the European Union.

They are as follows:

Number Reference of the standard
1EN ISO 10993-23:2021
Biological evaluation of medical devices – Part 23: Tests for irritation (ISO 10993-23:2021)
2EN ISO 11135:2014
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 11135:2014/A1:2019
3EN ISO 11137-1:2015
Sterilization of health care 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)
EN ISO 11137-1:2015/A2:2019
4EN 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)
5EN 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)
Sources:

Eurlex

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