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Team NB Perspective

Team NB Perspective on the Medical Devices Regulation in Europe

PascalePerspectives 2018-06-29T11:19:53+00:00

Latest News

Team-NB Academy is going on with training proposed to NBs only, the next training is on March 30th on “risk management”
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.
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.
In the framework of the Notified Bodies position paper on the Commission Notice 2021/C 8/01, the task force is working to develop a list of criteria to decide whether a remote audit is justified. The document will be presented again to the Commission.
The Notified Bodies are reviewing the Commission Notice 2021/C 8/01 published 11 January 2021. We are drafting a consensus paper so that we can approach our designating authorities with consistent risk assessment criteria to apply to remote audits. We hope to share our consensus paper before the end of January 2021.
EU Commission published an informative notice on the application of 2017/745 and 2017/746 regulations with regard to notified bodies audits performed in the context of quality management system assessment.
Team-NB members adopted a Position Paper for the interpretation of device related changes in relation to a Notified Body Opinion as required under Article117 of Medical Device Regulation (EU)2017/745.
Team-NB members adopted a Position paper on Directives expiring certificates – impacts and suggested solutions following a survey among NBs which took place in the automn.
The MDCG published a new guidance as MDCG 2020-17related to “Questions and Answers related to MDCG 2020-4”.

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