The Commission Implementing Decision (EU) 2021/1195 of 19 July 2021 on the harmonised standards for in vitro diagnostic medical devices drafted in support of Regulation (EU) 2017/746 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.
- 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 IVDR
In accordance with Article 8 of Regulation (EU) 2017/746 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, thereferences of which have been published in the OfficialJournal 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 in vitro diagnostic medical devices drafted in support of Regulation (EU) 2017/746 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|
|1||EN 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
|2||EN 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
|3||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)
|4||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)