The Medical Devices Introductory Course 2020

The Pre-Existing EU Medical Device Regulatory Landscape

• Medical Devices have been regulated under “ New Approach ” Directives since the 1990’s

• These involve manufacturers declaring conformance to a diverse range of generic quality, safety, performance and risk-based principles and attaching the “ CE Mark ”

• Except for some higher risk devices, this may be done without a third-party pre-approval assessment of data

• Attaching the “CE Mark” allows the manufacturer to immediately market the device in all Member States of the EU and, in addition, the EFTA markets (and helps achieve registration in many markets e.g.: Turkey, Canada and Australia, with similar requirements)

The 3 Medical Devices Directives Active Implantable Medical Devices Directive

– Directive 90/385/EEC* – Implemented: July 1992 – Pacemakers, neuromodulators and cochlear ear implants

(General) Medical Devices Directive – Directive 93/42/EEC* – Implemented July 1994

In-Vitro Diagnostic Devices Directive – Directive 98/79/EC – Implemented June 2000 – Pregnancy tests, blood glucose monitors, tests for transmissible diseases

[* As amended by 98/79/EC, 2000/70/EC, 2001/104/EC, EC No 1882/2003 and 2007/47/EC]

The Organisation for Professionals in Regulatory Affairs