Essentials of European Medical Device Regulatory Affairs - June 2020

Conformity Assessment Procedures - Options

Custom made devices: • Annex XIII • Class III: + QMS (via Annex IX or Annex XI Part A)

TheOrganisation for Professionals in Regulatory Affairs

Today’s Objective was... • To provide a basic understanding of European medical device regulatory requirements • Hopefully the objective was met Not covered • Annex XII : the format of certificates or • Annex XIII : what is required for custom made devices

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TheOrganisation for Professionals in Regulatory Affairs

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