As the EU Medical Device Regulation (MDR) has raised the level of scrutiny required to place a device on the EU market, startup cardiovascular device manufacturers, will have a better understanding on how to make the EU Regulatory process work for them to achieve a timely market access.

This presentation describes the main steps in the EU Regulatory process.

Objective
Strategies in understanding the requirements and generating regulatory compliant data throughout the certification journey in the following key areas: 

  • The players and their roles
  • Medical Device Definition
  • Device Classification
  • Conformity Assessment routes
  • GSPRs
  • Conformity Assessment process: QMS-and TD-requirements
  • Certification Decision Making
  • Affixing CE Mark
  • Post Market Surveillance

Agenda

  • Background: Regulation (EU) 2017/745
  • CE Mark Certification Process
  • Key Elements
  • Conclusions  

Target Audience: This webinar is aimed at regulatory professionals of legal manufacturers of cardiovascular medical devices who wish to access the EU market.

Language: English
Cost: No Charge

Can't make a live session? Register now and receive a complimentary recording after the live event. For further information, please contact: KN.NAM.Marketing@sgs.com

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