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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
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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.
The collection of datas for the Team-NB annual sector survey has been launched. The survey analyse is expected by end of March.
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