Module 16 2022

07/09/2022

MDCG Documents

MDCG 2020-7 • Post-market clinical follow-up (PMCF) Plan Template • A guide for manufacturers and notified bodies • April 2020 MDCG 2020-8 • Post-market clinical follow-up (PMCF) Evaluation Report Template • A guide for manufacturers and notified bodies April 2020

The Organisation for Professionals in Regulatory Affairs

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Patient Safety Alert UK

• NHS England and the MHRA work together to simplify and increase

reporting, improve data quality, maximise learning and guide practice to minimise harm from medical devices incidents by: • sharing incident data between MHRA and NHS England

• National Medical Devices Network Integrated reporting system became operational on 20 th September 2014

The Organisation for Professionals in Regulatory Affairs

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7