Medical Devices – Latest Updates

A new position paper on transfer agreement specifying the terms of voluntary change of notified body

6 October 2022

On October 5, 2022, the European Association for Medical Devices of Notified Bodies (Team NB) published a new position paper in connection with the implementation of the regulations on medical devices and on in-vitro diagnostics.

This position paper regulates the conditions for the voluntary change of the notified body under Regulation (EU) 2017/745 or Regulation (EU) 2017/746 and is a good contract template if the manufacturer concludes its contract with a notified body in relation to the conformity assessment of a product body and he wants to enter into a contract with another notified body. According to Article 58 of the (EU) MDR and Article 53 of the (EU) IVDR, the detailed specified precautions for changing the notified body must be clearly regulated and observed in an agreement between the manufacturer, the new notified body and the previous notified body.

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