Module 17 2024

03/12/2024

UK approach to medical devices advertising: high level view

Fairly liberal, subject to certain safeguards

Promotion to both HCPs and patients / consumers permitted

HCPs & Patients: same rules apply but execution of advertising must be tailored to the audience. Vulnerability of patients and carers must be respected!

Online advertising is permitted. Similar rules apply as for non-broadcast advertising

Sensitivity: Medical devices are within a very sensitive (and political) sector

Both legislative and self-regulatory regimes apply

Article 7 MDR-type (prohibition of misleading claims) – enforcement regime still under consideration

The Organisation for Professionals in Regulatory Affairs

TOPRA MSc Module 17

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UK medical device regulatory law & advertising

MHRA primarily responsible regulatory body

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Advertising to HCPs and patients permitted, including professional use products

Currently aligned with MDD

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Broadcast and non-broadcast (inc. online) advertising permitted

• Article 7 MDR-type (prohibition of misleading claims) changes anticipated 2025: • MHRA advertising committee – ABHI representative attending with other industry sector representatives (e.g. ABPI) • MHRA may hand over oversight to Advertising Standards Authority (ASA)

Claims must align with CE/UKCA marked ‘intended purpose’

Vigilance obligations apply to Manufacturer elicited social media comment

Risk that online user-generated comments may promote off-label

UK MD Regulations 2002: “supply” includes offer, exposure or possession for supply

Pre-CE/UKCA Mark: No advance orders but budget discussions likely allowable

The Organisation for Professionals in Regulatory Affairs

TOPRA MSc Module 17

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