Module 16 2022

02/09/2022

Regulation of Device Vigilance

• Formerly • Directive 93/42/EEC on medical devices (“MDD”)

• Directive 90/385/EEC on active implantable medical devices (“AIMD”) • Directive 98/79/EC on in vitro diagnostic medical devices (“IVDD”) • Replaced by • Medical Device Regulation (EU) 2017/745 (“MDR”) • IVD Regulation (EU) 2017/746 (“IVDR”) • Subject to transitional provisions linked to operation of EUDAMED2 database

• UK has not implemented MDR and IVDR • MDR and IVDR apply in Northern Ireland

The Organisation for Professionals in Regulatory Affairs

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Device Vigilance Responsibilities under the Directives

Medical Devices Directives

Commission Device Vigilance Guidance ● MEDDEV 2.12/1 rev 8 (from January 2013), plus forms ● Supplements directives but not legally binding

Additional national obligations

The Organisation for Professionals in Regulatory Affairs

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