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All News 2018-06-29T12:31:43+00:00

March 2021

February 2021

In the aim of dissemination of information, please note the Commission publication of a guidance entitled “Q&A on in vitro diagnostic medical device conformity assessment and performance in the context of COVID-19 ” which is available on their website.

covid-19_ivd-qa_en

It appears that there are differences in the approach between National Competent Authorities concerning the implementation the Commission Notice 2021/C 8/01 on remote audits under the Regulations (EU) 2017/745 and 2017/746 (MDR and IVDR). Therefore, at this time, Team-NB is unfortunately unable to finalise and publish its aligned position on the uniform implementation of such remote audits by Notified Bodies. The application of remote audits under MDR and IVDR due to pandemic-related contact and travel restrictions may currently vary across Member States depending on the governance provided by authorities.

Team-NB have shared their Position Paper on remote audits with the Commission and Designating Authorities. The authorities have communicated that they are working together on different levels (national, European) in order to achieve a Union-wide harmonised implementation of the Commission Notice 2021/C 8/01. The Team-NB paper is currently on hold as the authorities work to publish a harmonised approach.

January 2021

December 2020