Key Summary
- The MHRA published its draft pre-market regulatory requirements on the World Trade Organization (WTO) notification portal on Friday, May 8, 2026.
- Following the WTO notice, the MedTech industry, healthcare providers, and patients are now invited to share their views via an MHRA survey. Responses will directly shape the Impact Assessment and the final implementation of the law.
- Stakeholders have until 11:59 pm (UK time) on Friday, June 19, 2026, to respond.
The Medicines and Healthcare products Regulatory Agency (MHRA) has published draft pre-market regulatory requirements for medical devices and in vitro diagnostic (IVD) devices on the World Trade Organization (WTO) notification portal last Friday (8).
The notice invites WTO members to comment, while the MedTech industry, approved bodies, healthcare providers, and patients can share views via an MHRA survey.
Responses, due by 11:59 pm UK time on Friday, June 19, 2026, will shape the Impact Assessment and final implementation.
Key changes aim to speed access to safe, innovative devices while boosting UK MedTech growth:
- Framework for swifter approval of devices cleared by regulators in Australia, Canada, or the USA.
- Mandatory implant cards from healthcare organisations, detailing implanted devices for better adverse event management and patient transparency.
- Compulsory unique device identifiers (UDI) for lifecycle traceability.
- Alignment of IVD classifications and essential requirements with International Medical Device Regulators Forum (IMDRF) standards and global best practices.
- Strengthened technical documentation retention, plus new rules for custom-made devices (e.g., improved traceability, electronic prescriptions).
- Requirement for manufacturers' claims to match their intended purpose statement.
These proposals support the government’s ambition, outlined in the Life Sciences Sector Plan, to make the UK one of the top three fastest countries in Europe to access MedTech by 2030.
