Module 16 2022

9/2/2022

PMCF and MDCG 2020-6

PMCF Requirements

• In some cases, it may be necessary for the manufacturer to undertake PMCF to generate new data for these legacy devices prior to CE marking under the MDR, whereas in other cases, particularly for low risk standard of care devices where there is little evolution in the state of the art, it may be possible to demonstrate conformity with the relevant GSPRs with a more limited clinical data set. • Stable, well established technologies that perform as intended and are not associated with safety concerns, and where there has been no innovation, are less likely to be the subject of research, and therefore literature data may be limited or non-existent. In some cases, it may be necessary for the manufacturer to undertake PMCF to generate new clinical data for these devices prior to certification under the MDR, even if they are well established and have been on the market for several decades, to enable an evaluation of their safety and clinical performance in relation to an evolving state of the art.

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What is my PMCF Strategy…?

PMCF Strategy

• What is my legacy device need? • Device certification predicated on equivalence (no pre-CE mark clinical data) • Weak PMS data • Gaps in clinical data risking loss of indication/claim • Patient populations • Niche indications • PMS/risk management signals warranting further analysis • Device is WET but gaps in clinical data remain • Article 61(10) device lacking PMS data

• What factors/constraints need to be considered? • Quantity of devices already placed on the market • Clinical/scientific rationale for PMCF • Practicality of PMCF activities • Cost

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