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Expanding Data Collection Resources for CE Marked Products to Meet EU MDR Requirements

Antal Solyom (Director of Medical Device Unit, HungaroTrial)

Location: 210D

Date: Tuesday, February 5

Time: 3:15pm - 4:00pm

Track: MD&M West: Regulatory & Quality Update

Vault Recording: TBD

The EU MDR contains substantial changes in the requirements for providing clinical data. It is not acceptable to provide foreign clinical data but instead is mandatory to include clinical data derived from EU countries. What is the interpretation and practical adaptation of this rule? What are the main concerns regarding the design and sample size calculation of the clinical trial? All of these questions are real-life challenges for companies producing medical devices for EU distribution.

Topics covered include:
  • Where clinical data should come from (clinical trials only or other sources)
  • Is the combination of EU and non-EU countries in a clinical trial acceptable?
  • Protocols for following the marketed product as well as practices for the collection of safety and efficacy clinical data
  • How to expand data collection resources to include clinical data derived from EU countries

Presentation File