EU Remote Audits under Review
After the European Commission displaying a positive view towards remote audits in January, Team-NB has withdrawn its paper on the implementation of remote audits within the EU. It is cited that variations on the implementation of remote audits from country to country is the primary cause.
📢 Key Takeaways:
Member states have shown resistance to the use of remote audits and stress that national authorities are, in the end, responsible for the notified bodies.
Despite working on a harmonized approach to implementation of the notice to allow remote audits in January (LINK), Team-NB withdrew it’s position paper on the implementation of remote audits (LINK)
Despite the fact that “the vast majority of the Member States” see the need and potential for remote audits in exceptional circumstances, the Commission appears to confirm that a minority of countries are still opposed to remote audits.
Device coordinator group has agreed to meet in May with relevant stakeholders (LINK)
Team-NB Quotes
· “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. Despite working on a harmonized approach to implementation of the notice to allow remote”
· “It appears that there are differences in the approach between National Competent Authorities. Therefore, at this time, Team-NB is unfortunately unable to finalize and publish its aligned position on the uniform implementation of such remote audits by Notified Bodies”
đź“š Documents:
· MDCG 2021 Schedule : https://bit.ly/3eqEanh
· Team-NB Position Paper : https://bit.ly/3cdgBeI
· Team-NB Statement on Issues : https://bit.ly/38vikLt
