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TEAM-NB issues several new position papers

  • Posted by: inetika
  • Category: GLOBAL NEWS

TEAM-NB, the industry association for medical device notified bodies, has published a number of new position papers in recent weeks, including:

  • Transfer agreement template: specifying the terms of voluntary change of notified body under Regulation (EU) 2017/745 or Regulation (EU) 2017/746
  • Data generated from ‘off-label’ use of a device under the EU Medical Device Regulation 2017/745
  • IVD Class D measures in the absence of EU Reference Laboratories – Points to consider for Notified Body approach
  • Cybersecurity
  • Notified body approach for the Technical Documentation assessment approach of multiplex in-vitro diagnostic devices
  • Best Practice Guidance for the Submission of Technical Documentation under Annex II and III of Medical Device Regulation (EU) 2017/745

Copies of the documents can be obtained from the TEAM-NB website.