Module 18 - Drug Device Combinations and Other Technologies

12/7/2023

Frequency of updates: MDR

“updated throughout the lifecycle” (Article 61(11)) in accordance with PMCF Plan – at least annually for Class III and implantable devices Annex XIV Part B, PMCF plan must include “a detailed and adequately justified time schedule for PMCF activities (e.g. analysis of PMCF data and reporting) to be undertaken by the manufacturer. ” PMCF report forms part of the clinical evaluation report

See also MDCG 2020-7 Post Market Clinical Follow-up (PMCF) Plan template

See also MDCG 2020-8 Post Market Clinical Follow-up (PMCF) Evaluation Report template

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Lifetime Data

The PMCF plan shall specify the methods and procedures for proactively collecting and evaluating clinical data with the aim of: (a) confirming the safety and performance of the device throughout its expected lifetime , MDR Annex XIV Part B

What is your claimed lifetime?

Does your clinical data reflect this? If not how will you collect this data? Quantification of Risks and Benefit over lifetime is required.

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