The Medical Devices Introductory Course 2020

Changing Regulatory Structure in the EU

Active Implantable Medical Devices Directive (90/385/EEC)

In-Vitro Diagnostic Medical Device Directive (98/79/EC)

Medical Device Directive (93/42/EC)

[60 pages]

[37 pages]

In-Vitro Diagnostic Medical Device Regulation

Medical Device Regulation

[177 pages]

[158 pages]

The Organisation for Professionals in Regulatory Affairs

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The Changing EU Medical Device Regulatory Landscape

• “Regulation” versus current “Directive” • Key changes include new provisions for: • Classification changes (some devices ”up-classified”) • Person Responsible for Regulatory Compliance • Economic Operators • Unique Device Identification (UDI) / EUDAMED • Increased regulatory scrutiny and oversight (by EU Medical Device Co-ordination Group (MDCG)) • Post-market reporting • Products without a medical purpose • Coupled with extended or reinforced requirements for: • GSPR’s (previously Essential Requirements) • Clinical evaluation • Post-market surveillance • Retains the ‘New Approach’ CE Marking framework, with Notified Bodies as a contracted regulator