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  Team-NB welcomed a 27th member, namely IMQ – Italy, (Notified Body 0051)

Team-NB welcomed a 27th member, namely IMQ – Italy, (Notified Body 0051)

team-assist2022-04-08T18:19:26+01:00

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  On May 7th, the Commission is organising a webinar on MDR for patients. Links will follow.

On May 7th, the Commission is organising a webinar on MDR for patients. Links will follow.

team-assist2022-04-08T18:19:26+01:00

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  The Mirror MDCG WGs and TFs meeting will take place on April 13th remotely

The Mirror MDCG WGs and TFs meeting will take place on April 13th remotely

team-assist2022-04-08T18:19:26+01:00

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  Info from EU regarding Swiss Mutual Recognition agreement

Info from EU regarding Swiss Mutual Recognition agreement

Message- EU-Switzerland MRA - Information from the Commission

team-assist2022-04-08T18:19:27+01:00

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  Team-NB director is speaking at IMDS Virtual Networking : Asia

Team-NB director is speaking at IMDS Virtual Networking : Asia

team-assist2022-04-08T18:19:27+01:00

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  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.

team-assist2022-04-08T18:19:27+01:00

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  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-assist2022-04-08T18:19:28+01:00

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  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”

team-assist2022-04-08T18:19:28+01:00

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  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

team-assist2022-04-08T18:19:28+01:00

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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.

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.

team-assist2022-04-08T18:19:29+01:00

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