Module 17 2024

03/12/2024

CAP Codes – medical devices

• Medical claims only for CE/UKCA marked devices

• But a CE/UKCA mark is not evidence of efficacy

• Take care with “borderline” claims

• High standard of substantiation:

• Rule – objective claims must be backed by evidence, if relevant consisting of trials conducted on people • Guidance – sensory/impressionistic subjective claims vs uncontroversial/established objective claims vs “new” objective claims

• Must not falsely claim that a product is able to cure illness, dysfunction or malformations

The Organisation for Professionals in Regulatory Affairs

TOPRA MSc Module 17

13

ASA ruling Omega Pharma Ltd – 19 October 2022

• CE marked nasal cleansing spray

• “Each day we breath [sic] in millions of viruses which can lead to cold symptoms. Clean your nose every day with new BecoCleanse ... It cleanses away viruses and helps protect against winter symptoms” • ASA: implied claim that the product would protect against viruses and help prevent cold symptoms

The Organisation for Professionals in Regulatory Affairs

TOPRA MSc Module 17

14

7