Module 16 2022

9/2/2022

Post-Market Surveillance – General Policy

Section I – POST-MARKET SURVEILLANCE Article 83 – Post-market surveillance system of the manufacturer The post-market surveillance system shall be suited to

• actively and systematically gathering, recording and analyzing relevant data on: • the quality, performance and safety of a device throughout its entire lifetime, and; • to drawing the necessary conclusions and to determining, implementing and monitoring any preventive and corrective actions

Design, Manufacture

Shelf-Life

Use Life

Placement on Market

Point of first use

Time from data manufacture to the claimed use-by date

Number or period of subsequent uses

Disposal or Decommission

Pre-market phase

Conception

Life-cycle ISO 14971: All phases in the life of a medical device, from the initial conception to final decommissioning and disposal

The Organisation for Professionals in Regulatory Affairs

9/2/2022

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Overview of MDR Regulations for legacy devices

During the MDR transitional period, legacy devices must comply with post-market surveillance requirements of the MDR.

MDCG 2021-25 states that this includes post-market surveillance reports (PMS reports) and periodic safety update reports (PSURs) for legacy devices as well Vigilance reporting, Collection of PMCF and/or clinical data Registration of the device and economic operator in EUDAMED. MDR requirement Application to ‘legacy devices’

Art. 10(10), (12)-(15) - General obligations of manufacturers

YES ( nota bene : ‘conformity with the requirements of this Regulation’ shall mean for ‘legacy devices’ conformity with the MDD or AIMDD and the additional requirements in accordance with Article 120(3) MDR) YES ( nota bene : ‘conformity with the requirements of this Regulation’ shall mean for ‘legacy devices’ conformity with the MDD or AIMDD and the additional requirements in accordance with Article 120(3) MDR)

Art. 11(3)(c)-(g) - Authorised representative

Art. 11(7) - Authorised representative

YES

Art. 13(2), 2nd subparagraph, (4), (6)-(8),(10) - General obligations of importers

YES ( nota bene : ‘conformity with the requirements of this Regulation’ shall mean for ‘legacy devices’ conformity with the MDD or AIMDD and the additional requirements in accordance with Article 120(3) MDR)

The Organisation for Professionals in Regulatory Affairs

9/2/2022

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