MDR/IVDR Standardisation Request

As we can read in the recently published minutes from the 19th June meeting of the MDCG sub-group on Standards, CEN and CENELEC rejected the Commission Standardisation Request motivating such a decision mainly on some of the requirements of Annex III, in particular with respect to the interrelation between international and European standardisation, asking for “identical standards”.

The Commission needs to now relaunch the whole process for a new MDR/IVDR Standardisation Request, and does not expect the procedure to be completed before Q1 2021! As it involves drafting, submission to the Committee on Standards for their opinion, then adoption as a new Implementing Decision and notification to CEN and CENELEC for their acceptance.

Another interesting point of the discussion was around the issue of ”possible inconsistent approach for implementation of standards, for instance by notified bodies with respect to the concept of “state of the art”, …, as harmonised European standards cited in the OJEU may not be the latest version available. COM confirmed that the EU legislation on medical devices refers to the need to “take into account the generally acknowledged state of the art30; however, it is not a legally defined concept31. Therefore, it could be worth elaborating more on this, to clarify the use of standards in such cases, through a guidance document dealing with different issues related to medical devices standardisation; it could be drafted by COM and discussed and endorsed by the MDCG in the next months.”

Moreover, the European Commission recalled the Commission Implementing Decisions in support of the current Directives on medical devices published in March 2020 and stated that those standards may not be used to confer presumption of conformity with the requirements of the new Regulations. For the new Regulations, it is necessary to have a specific publication of references to standards on the basis of a new Standardisation Request …”

Minutes can be found under the icon ”Standards” and ”MDCG” at our Library of Documents.

Minutes of the 25th May meeting with stakeholders of the MDCG sub-group IVD were also published, and below you can find some interesting points:

”Regarding expert panels, selection of experts has been completed and the Commission is working on setting up the secretariat.”

The stakeholders enquired whether class D devices were the priority for the work on implementing the IVDR. This was confirmed.”

”Regarding COVID-19 tests and possible amendment of IVDD Annex II to include them, the stakeholders highlighted that given the time needed (several months) for the procedure and transition period to allow market operators to adjust, the duration of the application of such an amendment would be rather short before the IVDR comes into application on 26 May 2022. This concern brings the added value of the amendment into question. They also raised the need to consider timing as by the time the Annex is amended, the epidemic may be at a different stage. The Commission noted that this could be a medium-term measure, while needs in the short term may be served by guidance on COVID-19 device performance. The next steps will be considered by the competent authorities. ”

All published Minutes can be found under the MDCG icon in our Library of Documents.

Leave a Reply

Your email address will not be published.