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March 2021

Team-NB Academy: 3rd session of Clinical data Training: following the success encountered by the 2 June sessions, already fully booked, a 3rd session has been planned in September, it is a new step to improve harmonization between members.

Team-NB Academy: 3rd session of Clinical data Training: following the success encountered by the 2 June sessions, already fully booked, a 3rd session has been planned in September, it is a new step to improve harmonization between members.

The Ordinary General Assembly of the association will take place remotely on April 14th

The Ordinary General Assembly of the association will take place remotely on April 14th

Team-NB Academy is going on with training proposed to NBs only, the next training is on March 30th on “risk management”

Team-NB Academy is going on with training proposed to NBs only, the next training is on March 30th on “risk management”

February 2021

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.

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.

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.

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.

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.

January 2021

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.

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.

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.

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

December 2020

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 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