The UK MedTech Forum, which PAGB is a member of, has shared its recommendations with the Medicines and Healthcare products Regulatory Agency (MHRA) to support regulatory reforms aimed at improving patient outcomes and fostering innovation within the UK HealthTech sector.
In a letter to Lawrence Tallon, CEO at the MHRA, members of the Forum have emphasised the importance of sustainable and efficient regulation to maintain the UK’s global competitiveness and encourage investment in domestic innovation.
The letter urges MHRA to prioritise the following measures:
- Recognition of EU CE-marked devices:
With a view to maintaining the current arrangements for CE-marked devices and avoid the introduction of any new requirements, the Forum has called for an indefinite near-automatic recognition mechanism for CE-marked devices under EU regulations to reduce duplication, regulatory costs, and ensure patient access to safe, effective medical devices.
- Internationally aligned reliance pathways:
The letter highlights the need for a streamlined reliance-based pathway for premarket approvals from trusted international regulators, reflecting international best practice and ensuring proportionate oversight, particularly for SMEs and innovative technologies.
The UK MedTech Forum highlights the urgency of addressing systemic regulatory barriers and calls for accelerated implementation of alternative routes to market. The letter also underscores the MHRA’s opportunity to lead international harmonisation through its membership in the International Medical Device Regulators Forum (IMDRF).
Members of the Forum remain committed to collaborating with the MHRA to co-develop a regulatory framework that ensures better patient outcomes and a thriving HealthTech ecosystem.
Read the full letter here.
