Module 16 2024

21/10/2024

PMCF and MDCG 2020-6

• 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…?

• What is my legacy device situation?

• Device certification predicated on equivalence (no pre-MDD CE mark clinical data)

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Weak PMS data

• Gaps in clinical data risking loss of indication/claim

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Patient populations

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Niche indications

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Other residual risks

• 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

• Location of devices on the market (e.g., how may devices in the EU market)

• Clinical/scientific rationale for PMCF

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Practicality of PMCF activities

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Cost

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