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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.

By | 2021-02-25T10:44:46+00:00 February 25th, 2021|news|0 Comments

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.

By | 2021-02-19T12:34:36+00:00 February 3rd, 2021|news|0 Comments

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.

By | 2021-02-19T12:34:55+00:00 January 20th, 2021|news|0 Comments

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.

OJ_JOC_2021_008_R_0001_EN_TXT

By | 2021-02-19T12:35:31+00:00 January 11th, 2021|news|0 Comments

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-NBPosition-Paper-Art117SubChangeLifeCycleMngt-202012

By | 2021-02-19T12:35:42+00:00 December 21st, 2020|news|0 Comments