Med-tech device regulation is undeniably important to ensure the quality and safety of products for patients and users. However, the regulatory landscape has become so complex and expensive to navigate that it is now one of the biggest barriers to market entry. KPMG's 2025 study on Unlocking the Potential of UK Health Tech explained that 'High costs associated with regulatory approval, including compliance with the UKCA mark alongside the CE mark, were emphasised as a drain on resources and funds'. The recent regulatory changes therefore appear to be directly responding to these concerns.

So, What is Changing?

1. UKCA Regulatory Marking Set to be Dropped
Finally! A regulatory change that may make life easier for medical device manufacturers. The MHRA has confirmed it will remove the requirement to physically display the UKCA marking on medical devices and packaging. However, this will only come into place once Unique Device Identification (UDI) is fully implemented and searchable in a public database. This change aims to reduce burden on manufacturers and enhance traceability and post-market surveillance. Importantly, existing UKCA labels may remain in place voluntarily.
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2. New International Reliance Routes for Faster Market Access
Manufacturers can now access streamlined entry routes into Great Britain for products already approved by trusted regulators in the US (FDA), Canada (Health Canada), and Australia (TGA). This includes specific software as a medical device and implantable devices that meet UK equivalence criteria. Third-party Approved Body review will be required for certain device classes.
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‍3.Consultation to Recognise CE‑Marked Devices Indefinitely
Although CE‑marked devices continue to be accepted under current transitional rules until 30 June 2028 or 2030 (depending on device type), the MHRA will launch a consultation later this year on indefinitely recognising CE‑marked medical devices in the UK.

‍4. Class B IVDs: Risk‑Proportionate Regulation
Under the new framework, Class B in vitro diagnostic (IVD) devices will follow a more proportionate regulatory route: Manufacturers can self-declare conformity with UK Medical Devices Regulations 2002. However, such manufacturers must hold ISO 13485 QMS certification from UKAS or accredited bodies in CPTPP countries and these IVD categories remain eligible for reliance pathways.
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What is the timeline for these changes?‍

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The “Pre-Market” statutory instrument (SI), including UDI requirements and updates to IVD classifications, will be introduced later in 2025 and notified to the World Trade Organization.
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What are the key transition periods?
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General devices have 3 years to comply with the changes. IVDs have up to 5 years to comply with UDI and related changes. Further consultation will address the scope of CE‑mark recognition.
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Why does this matter for UK MedTech Stakeholders?
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Founders & Startups: Reduced labelling cost and faster routes from trusted regulators help speed up market entry.

Regulatory Teams: UDI and reliance frameworks need preparation. Review device classification and Q systems now.

Investors & Innovators: The UK's evolving Life Sciences Sector Strategy signals a more agile, growth-oriented environment for digital health and device innovation.

The UK’s regulatory shift will hopefully mark a pivotal moment. UKCA labels phased out, CE‑mark recognition under review, UDI-enabled traceability, and international reliance channels opening. Together, these measures signal a strategic shift toward efficient, globally-aligned regulation and a more attractive environment for MedTech innovation in the UK.
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Additional resources for the official MHRA statement and government response
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‍MHRA response to consultation on international reliance, UKCA marking and IVDs (gov.uk)Innovation News NetworkTechUK‍

Disclaimer: This blog summarises recent regulatory changes and consultative directions from the MHRA as of July 2025. Please refer to official MHRA guidance and legal counsel for compliance decisions.

This Blog Covers:
- MHRA UKCA marking removal - UDI introduction - International reliance routes (FDA, TGA, Health Canada) - CE mark indefinite recognition - Class B IVD self-declaration & ISO 13485 - Pre‑market reform - UK Medical Devices Regulations 20021 - UKCA Marking Requirement Set to Be Dropped.