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PascalePerspectives
2019-01-22T15:12:22+00:00
To improve communications with all stakeholders
To promote high technical and ethical standards
To participate in improving the legal framework
To represent Notified Bodies
To contribute to harmonization
Team-NB Documents
NB-MED documents
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.
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