The Medical Devices Introductory Course 2020

Legislation

EU Medical Device Regulation (MDR)*: Merged Medical Devices Directive (MDD) (93/42/EEC) and Active Implantable Medical Devices Directive (AIMDD) 90/385/EEC EU Regulation 2017/745: Entry into force 26 May 2017 Originally applicable 26 May 2020 EU Regulation 2020/561: Entry into force 24 April 2020 Application date deferred by one year to 26 May 2021 due to Covid-19 pandemic (Article 59 scope also extended)

*EU Regulation 2017/745 as amended and consolidated (inclusive of the amendment effected by EU Regulation 2020/561)

The Organisation for Professionals in Regulatory Affairs

What is it and why it is needed? CLINICAL EVALUATION

The Organisation for Professionals in Regulatory Affairs