The European Commission has issued (Jan 4th and Jan 6th) two new implementing decisions to add to the list of harmonised standards to support Medical Device Regulation (MDR) and In-Vitro Diagnostics Medical Device Regulation (IVDR)
This is good news and adds to the number of standards that provide a “presumption of conformity” to these regulations. This is something that will be welcomed by medical device manufacturers, economic operators, and conformity assessment bodies. Harmonised standards are a useful tool in demonstrating how manufacturers products and processes meet the new MDR and IVDR regulations.
European Commission implementing decisions
Implementing Decision (EU) 2022/6 issued on the 4th of January 2022 applies to the MDR and cites an additional 9 standards. This decision amends Implementing decision (EU) 2021/1182 and means there are now a total of 14 Harmonised standards for the MDR.
Implementing decision (EU) 2022/15, issued on the 6th of January 2022, applies to the IVDR and cites an additional 5 standards. Again this decision amends implementing decision (EU) 2021/1195 and results in a total of 9 standards cited for the IVDR.
Horizontal Standards Cited
There are a couple of horizontal standards listed in these new implementing decisions:
- I.S. EN ISO 13485:2016/A11:2021 – Quality management systems – Requirements for regulatory purposes
- I.S. EN ISO 15223-1:2021 – Medical Devices – Symbols to be used with information supplied by the manufacturer – Part 1: General requirements
“Horizontal standards” have broad application and are used by manufacturers irrespective of the type of device involved. The inclusion of the above horizontal standards is a welcome development, particularly the inclusion of the quality management system standard.
Other types of standards listed included address sterilisation, aseptic processing and biocompatibility testing, see implementation decision links above for more information.
Cited standards available on NSAI Standards store
All cited standards are available on the NSAI published standard catalogue where you can search and view up to the scope of many standard for free – check the following link
It is expected that the Commission will issue further implementing decisions to add to the list of Harmonised standards later in 2022, with updates expected every 6 months or so.
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