New pre-market regulatory requirements for placing medical devices and in vitro diagnostic devices (IVDs) on the GB market have been published. This is the long awaited next step in the Medicines and Healthcare products Regulatory Agency (MHRA) programme of regulatory reform of the medical device framework, following last year's post-market surveillance (PMS) requirements.
For over 20 years, the Medical Devices Regulations 2002 have provided the regulatory framework for medical devices in Great Britain. Over that time, there have been significant developments in technology, clinical practice, and healthcare delivery which have necessitated the modernisation of the framework.
The new standalone regulatory framework is set out in the draft Medical Devices (Amendment) Regulations 2026, available on the World Trade Organization portal. The proposed date of adoption for the regulations is December 2026 and it is anticipated that they will enter into force in June 2027. Transitional provisions of three years for general medical devices and five years for IVDs will apply to enable time to implement the new provisions and avoid supply chain issues.
Key reforms include:
- The introduction of an international reliance pathway to enable swifter access for devices already approved by comparable regulator countries in Australia, Canada and the USA. The indefinite recognition of EU CE marks, the main route to the GB market for over 90% of medical devices, is already under separate consideration by the MHRA;
- Aligning risk-proportionate classification rules for devices with those of the International Medical Device Regulators Forum (IMDRF) standards;
- Aligning the essential requirements for medical devices in GB with best international practice;
- Strengthening the requirements for technical documentation retention;
- Unique device identifiers (UDI) will be compulsory, enabling identification and traceability of devices throughout their lifecycle;
- Healthcare organisations that implant medical devices must give patients implant cards with information about the device;
- Expanded use of electronic instructions for use; and
- Manufacturers must align claims about their medical devices with their statement of intended purpose with controls on misleading or unsubstantiated claims in advertising.
Provisions relating to software medical devices have not been updated, presumably awaiting the findings of the National AI Commission in summer 2026.
The direction of travel of these draft regulations follows the consultations that have been carried out since the MHRA became a sovereign regulator and as such, do not come as a surprise. However, it is the practical implementation that will inevitably prove a challenge and by which success will be measured. It remains to be seen to what extent additional guidance will ease the transition.
The MedTech industry, approved bodies, healthcare providers and patients are invited to share their views on the proposed changes via an MHRA stakeholder impact survey. This is open until 19 June 2026 and the responses will inform the Impact Assessment and future implementation of the regulations. The deadline for WTO comments is 7 July 2026.
