« All News & Opportunities

19th May 2026

Medilink UK: Draft Medical Devices (Amendment) Regulations 2026 – what you need to know

The Medical Devices (Amendment) Regulations 2026 have now been published by the MHRA. 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.

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?

  1. 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.
  1. 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.
  2. 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.
  1. 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.

5 .New rules for software change management (PCCPs)
Formal Predetermined Change Control Plans are introduced for software, including AI‑enabled devices. These allow manufacturers to pre‑define certain future changes without repeated conformity assessments, provided changes remain within an approved plan and are supported by robust QMS, risk management and post‑market data.

  1. International Reliance Pathway
    A new route to GB market access based on approval in the US, Canada or Australia. Scrutiny is risk‑based: low‑risk devices may self‑register with QMS confirmation, while higher‑risk devices will undergo targeted approved‑body review for GB‑specific requirements, PMS and implant card obligations. .

What should manufacturers do now?

  • Review claims and clinical evidence, particularly for legacy products.
  • Check IVD portfolios against the proposed new classification rules.
  • Assess whether software change processes could support PCCPs.
  • Consider how the International Reliance Pathway may affect future market access and competition.
  • Engage with the MHRA consultation while it remains open (MHRA invites views on proposed changes to medical device regulation – GOV.UK)

The Medilink specialist consultancy team can provide advice and support your regulatory journey for the UK, EU and international markets.  Please contact regulation@medilink.co.uk   for an informal discussion regarding how we can support you with your regulatory needs.

Disclaimer: This article is intended for general information only and does not constitute legal or regulatory advice. The Draft Medical Devices (Amendment) Regulations 2026 are subject to consultation and may change before being finalised. Organisations should seek specific professional advice before taking or refraining from any action based on this information.