Appropriate surveillance regarding Article 120(3) of MDR and Article 110(3) of IVDR for legacy device

This Deep Dive session will address what is necessary to ensure that the surveillance according to the key MDCG papers is appropriate. Furthermore, we will clarify what you can expect from a Notified Body.
Topics will be, e.g.:

  • Does the manufacturer need to update the technical documentation?  
  • Does the manufacturer need to prepare a periodic safety update report (PSUR)?                                                                                                                                                   
  • Is the technical documentation of legacy devices still sampled?

In a final Q&A session, we will answer your questions.

Date and time: Monday, 24 October 2022, 7:00 pm (CEST​​​​​​​/ 1.00 pm (EDT)

Your speakers: Dr Alexandra Seber, Global Process Owner Technical Documentation


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