Module 17 2024

04/12/2024

Interrelation of promotional claims and validated ‘intended purpose’, safety and performance

Promotion outside validated ‘intended purpose’, safety and performance is ‘off - label’

Undermines protective ringfence which validated “intended purpose,” safety, and performance provides against third party claims

Not covered by valid CE marking

• All product

claims should also align with the validated SSCP • Implantables and Class III medical devices and Class C and D IVDs

MDR: public Summary of Safety and Clinical Performance (SSCP) – Art.32 MDR, Art.29 IVDR:

All product claims should therefore align with ‘intended purpose’, safety and performance as validated by

Manufacturer, including oral statements, demonstrations and promotional materials

New EU PLD’s defect test: regulatory compliance is taken into account as one of the circumstances to be considered.

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Implications for product liability

• Supply chain players • PRRC • New EU disclosure orders

Visibility

Spotlight on device status as part of “defect” test

• NB certificates status • FSCA/FSN, etc

• IFU, SSCP, claims • “failure to warn” / information defects

Vigilance -v- Warnings

• Key importance of Technical Documentation

Evidencing compliance

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