The Medical Devices Introductory Course 2020

Vigilance

MDR 2017/745, Article 88..

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“Trend Reporting”

• Sets out requirements for reporting adverse trends of ‘ non serious incidents ’. i.e. those that are not considered to meet the criteria for vigilance but which could nonetheless have a significant impact on the risk benefit ratio.

• Provides link back to PMS plan: Manufacturer must specify methodology for determining significant increase in severity or frequency in the PMS plan..

• Establishes requirement for NCA to review trend report, adopt appropriate measures with the manufacturer and inform the Commission, other NCA’ s and NB of said measures

The Organisation for Professionals in Regulatory Affairs

Vigilance

MEDDEV 2.12-1 rev 8

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“Guidelines on a Medical Devices Vigilance System”

– Not legally binding BUT (1)….

– Prepared by and therefore reflecting the expectations of Notified Bodies, Competent Authorities, The European Commission and Industry

– Adherence to the MEDDEV strongly recommended

– BUT (2)….

– Written to support the MDD and IVDD and not yet updated for MDR & IVDR

The Organisation for Professionals in Regulatory Affairs