The Medical Devices Introductory Course 2020

Medical Devices - Scope

The Organisation for Professionals in Regulatory Affairs

The MDD/ MDR – Key ‘ Players ’

EU Commission – develops the legislative framework and policy; interprets and arbitrates where disputes arise / MDR adds MDCG expert group Competent Authority – Member State government agency responsible for monitoring medical devices, reviewing clinical investigation notifications and accrediting ‘Notified Bodies’ in their market Notified Body – an independent, third-party conformity assessment body or test-house responsible for assessing medical devices and their ‘Manufacturers’ for compliance with the requirements of the MDD (70 54 different ones to chose from … for now!) and MDR (only 14 for now). Manufacturer – legal entity responsible for placing device on the EU (EEA) market under their own name EU Authorised Representative (EU-REP) - legal person established in the EU who, explicitly designated by a non-European manufacturer, acts on his behalf in carrying out certain tasks required in the applicable directives. Economic Operators – include manufacturers, EU-REP, importers and distributors