UK Medical Devices Reform: MHRA Publishes Draft 2026 Regulations and Launches Impact Survey

What is changing — and how this aligns with earlier consultations

Broadly, the Draft Regulations track the direction from prior MHRA consultations and aim to modernise the current UK regulatory framework and maintain alignment with international regulatory practice. Key reforms include:

• An International Reliance scheme, allowing devices authorised by regulators in comparable jurisdictions (currently Australia, Canada and the United States) to access the Great Britain market via a reliance‑based pathway.
• Revised classification rules for general medical devices, active implantable medical devices and in vitro diagnostic (IVD) devices.
• Re‑anchoring of UK essential requirements, drawing on EU MDR and IVDR concepts (as modified for the UK framework).
• Expanded technical documentation requirements, including extended retention periods (device lifetime plus 10 years, and 15 years for implantable devices) to support post‑market surveillance.
• Mandatory adoption of Unique Device Identifiers (UDI) for medical devices and IVDs, together with implant cards for implantable devices, to strengthen traceability.
• Tighter rules on claims of equivalence to existing devices.
• New controls on misleading/unsubstantiated device claims.
• A Predetermined Change Control Plan (PCCP) pathway for software medical devices, intended to streamline regulated software updates, alongside explicit cybersecurity obligations.
• Broader circumstances where electronic instructions for use (IFUs) may replace paper IFUs.

International Reliance Pathway - clarity on scope and mechanics

The Draft Regulations confirm international reliance will operate as a stand‑alone route to market, allowing eligible devices to obtain a Certificate of International Reliance without the need for UKCA marking.

The International Reliance pathway is limited to devices authorised in the US, Canada and Australia. The EU is not included and the Draft Regulations do not establish CE‑marking as a stand‑alone route for placing new devices on the market in Great Britain; this is being considered separately through the MHRA’s consultation on the indefinite recognition of CE‑marked devices, which closed on 10 April 2026. In practice, manufacturers should anticipate continued CE‑mark recognition, while closely monitoring the MHRA’s final policy decision on its scope, duration and any associated conditions.

The MHRA’s impact survey — purpose and what it will do

The stakeholder survey launched in parallel to the Draft Regulations will supply the evidence base for the formal impact assessment report on the Draft Regulations. The MHRA is seeking data to:

• Quantify costs and benefits arising from the proposals, including impacts on pre‑market conformity assessment, clinical evidence generation, post‑market surveillance and vigilance, labelling and UDI implementation, and economic operator obligations.
• Test international alignment, including the extent to which reliance on existing technical documentation, clinical evidence and PMS systems could reduce duplication.
• Inform transitional arrangements to identify potential pressure points (such as Approved Body capacity) and how phased implementation could minimise disruption.

The survey is limited to the Draft Regulations and respondents are asked not to include impacts arising from other legislation. While such dynamics fall outside the formal cost/benefit analysis, they may nevertheless be relevant context for survey responses.

The survey closes on Friday, 19 June 2026 at 11:59pm (UK time).

Why the timing matters — interaction with EU MDR changes

The publication of the Draft Regulations follows the European Commission’s proposals to simplify aspects of the EU MDR and IVDR. This timing leaves open the question of how closely the UK reforms will align with the amendments to the EU MDR and IVDR. Proposed EU amendments affecting classification, clinical evidence requirements and post‑market obligations could increase regulatory divergence, potentially adding cost and complexity for European manufacturers.

Adoption of the UK Draft Regulations is anticipated in December 2026 with provisions entering into force in June 2027 and the International Reliance Pathway following in mid 2028.

Authored by Jane Summerfield, Bonella Ramsay, Alexandra Wood and Jeanne Lintonbon.