[WEBINAR] Clinical Evaluation Reports

UPDATES RELATED TO MDR FOR AUSTRALIAN COMPANIES

 

Currently, we observe that the reviewers of Notified Bodies during MDR conformity assessments are gradually converging in terms of review practices and acceptance criterion. During this webinar, you will get an overview of the latest updates related to the preparation of clinical evaluation reports (CER).

 

Our expert Dr Jérôme Randall will guide you through:

  • The notions of “performance-based CER” and “well-established technologies”
  • Methods for scoping and launching simplified PMCF (Post Market Clinical Follow Up) studies for gathering the clinical data that may be missing.

 

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