The Medical Devices Introductory Course 2020

Contents

• Post Market Surveillance

• What is PMS? Legal & Regulatory Basis

• The PMS System – some practical advice

• Vigilance

• What is Vigilance? Legal & Regulatory Basis

• The Vigilance system – some practical advice

• Field Safety Corrective Action

• What is FSCA? Legal & Regulatory Basis

• Conducting an FSCA – some practical advice

The Organisation for Professionals in Regulatory Affairs

Regulatory basis

 NEW European Medical Device Regulations (EU) 2017/745 reinforces safety and performance provisions of existing Med Dev Directive (MDD 93/42/EEC)

Date of Application 26 May 2020 2021

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26 May 2017 •MDR, IVDR adopted by European Commission

26 May 2022 •IVDR DoA (5 years transition from IVDD)

26 May 2020 2021 •MDR DoA •COVID-19 delay (3 4 years transition from MDD)

The Organisation for Professionals in Regulatory Affairs