The draft Regulations have been notified internationally for comment and are also the subject of a live MHRA stakeholder survey, open until 19 June 2026.
These Regulations represent the main reform of the GB medical device framework and are intended to modernise pre‑market requirements while improving access to devices already approved in other major jurisdictions.
Author: Medilink Specialist Consultancy Team – Dr Patrick Trotter and Mrs Stefanie Read.
When will the changes apply?
The draft Regulations are split into two parts:
- Part A: Access to the GB market
Expected to come into force around 6 months after the Regulations are made, likely Q4 2026. - Part B – International Reliance Pathway (IRP)
Expected to commence 18 months after making, likely Q2–Q3 2028.
What are the main changes?
Closer alignment with EU MDR and IVDR (adapted for GB)
The proposals realign GB requirements with EU MDR and EU IVDR but modified for UK use. These include:
- Updating UK Essential Requirements to align with EU General Safety and Performance Requirements.
- Clearer rules on intended purpose and equivalence.
- Mandatory implant cards for implantable devices.
- Major reform of IVD classification, aligning with the IMDRF/EU IVDR risk‑based system (Classes A–D), with increased approved‑body involvement for higher‑risk IVDs.
Stronger control of claims and intended purpose
Claims will be regulated more explicitly. Intended purpose now covers labelling, IFU, promotion and technical documentation, meaning all claims about benefit, population and performance must be supported by evidence, primarily through the clinical evaluation report. There will be less tolerance for generic or legacy claims.
Reinforced lifecycle requirements
The Regulations confirm:
- Mandatory UDI
- Expanded technical documentation
- Strengthened post‑market surveillance, much of which is already in force but now consolidated into the new framework.
New requirements for custom made devices
This covers specific requirements for the traceability of custom‑made devices, including identification of the manufacturer, the authorised healthcare professional, and the individual patient. There are also explicit provisions for electronic prescriptions, alongside strengthened expectations for the technical documentation. In particular, manufacturers must clearly demonstrate that the device meets the essential requirements applicable to custom‑made devices and that it conforms precisely to the prescription. There is also a requirement for proportionate PMS and vigilance.
