UK MedTech Forum letter to MHRA urges recognition of EU-CE marked devices and international reliance pathways
The UK MedTech Forum, of which the Proprietary Association of Great Britain (PAGB) is a member, has written to the Medicines and Healthcare products Regulatory Agency (MHRA) recommending regulatory reforms aimed at improving patient access and supporting innovation in the HealthTech sector. In a letter addressed to MHRA Chief Executive Lawrence Tallon, the Forum called for the indefinite recognition of EU CE-marked medical devices to prevent regulatory duplication, reduce costs, and maintain timely access to safe and effective technologies. It also advocated for the introduction of internationally aligned reliance pathways for premarket approvals, enabling streamlined oversight based on approvals by trusted foreign regulators. Emphasising the need to eliminate systemic barriers and fast-track alternative routes to market, the Forum underlined MHRA’s opportunity to promote global harmonisation through its role in the International Medical Device Regulators Forum (IMDRF). Forum members expressed their ongoing commitment to working with MHRA to co-develop a regulatory framework that improves patient outcomes and strengthens the UK HealthTech ecosystem.