Module 5 Presentations

16/07/2024

• Scope of MDR much greater than CTR • whole product life-cycle regulation • Terminology more different than definitions • … but “the devil is in the details” • Less Clinical evidence my be required for device safety and efficacy (eg smaller single-phase trials) • due to the greater certainty from lab testing and range of statistical analyses • MDR-EUDAMED ≅ CTR EU-portal and database interoperability • MDR ISO 14155 ≆ or ≇ CTR ICH-GCP • Data Protection, AI both GDPR, AIA • Devices have lower threshold for disclosing IP, trade secrets MDR compared to CTR

The Organisation for Professionals in Regulatory Affairs

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If you remember nothing else:

If it is impossible to otherwise establish with a sufficient degree of certainty, considering the inherent hazards of the situation, the real-world safety and performance of a medical device is sufficient to meet the GSPRs of the MDR … … then a focused limited clinical investigation on human subjects/material may be required, if and only if other testing strongly indicates a positive outcome.

If GSPRs can be otherwise established, they should be and the product CE Marked before it is used on a human.

The Organisation for Professionals in Regulatory Affairs

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