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What MHRA's January updates mean for your business
Welcome to our weekly newsletter. Each week we will share practical regulatory updates with a clear focus on what changed, why it matters, and what teams should do next.
Borderline products: how MHRA decides if your product is a medicine
The MHRA borderline products guidance was last updated on 12 January 2026. (GOV.UK) It is a useful reset for any product that could sit between medicines, devices, cosmetics, supplements, herbals, or biocides.
The MHRA borderline products guidance was last updated on 12 January 2026. (GOV.UK) It is a useful reset for any product that could sit between medicines, devices, cosmetics, supplements, herbals, or biocides.
What MHRA is reinforcing
- Claims and overall presentation drive outcomes. MHRA looks at the full picture, including labels, packaging, websites, and promotional content. A product can be treated as a medicine even if it looks like a cosmetic or supplement, if the presentation points toward prevention or treatment of disease.
- Mode of action is a major lever. If the intended primary effect is achieved via pharmacological, immunological, or metabolic action, the product is more likely to fall under medicines regulation.
- “It is classified differently in another country” does not settle the UK position. MHRA assesses against UK legal definitions and the evidence in front of them.
What you can do this week
- Run a quick internal check on your claim set: do any phrases imply diagnosis, prevention, treatment, relief, or cure?
- Stress test your “how it works” narrative: does it imply a pharmacological or metabolic effect even indirectly?
- If the product is truly borderline, plan early for the right pathway and evidence strategy, before brand and marketing materials become expensive to unwind.
UK medical devices: January 2026 guidance refresh that affects UKCA planning, registration, and study timelines
Several core GOV.UK device guidance were refreshed in January 2026, and together they clarify the stepwise route to market and the common traps that cause delay.
Key updates worth actioning
- UKCA conformity assessment guidance was last updated on 15 January 2026, including an updated conformity assessment flowchart. This is central for mapping classification to the correct conformity route for Great Britain, with separate rules for Northern Ireland (CE / CE UKNI). (GOV.UK)
- Device registration guidance was last updated on 16 January 2026 and highlights operational changes: registration sits alongside conformity assessment (it is not an approval), and new registration fee management is being implemented. The guidance indicates an estimated annual fee from 1 April 2026 in the region of GBP 300 per year per Level 2 GMDN category, plus practical account management implications for continuing to place devices on the market after that date. (GOV.UK)
- Clinical investigations guidance was last updated on 14 January 2026 and repeats a planning critical: where notification is required, you must inform MHRA at least 60 days before starting the investigation. It also notes that notification is not required for devices already UKCA, CE, or CE UKNI marked for the purpose under investigation. (GOV.UK)
- Health Institution Exemption guidance was last updated on 20 January 2026 and provides scenario-based expectations for health institutions manufacturing or modifying devices for internal use, including clarifications on transfer and use outside the institution’s premises. (GOV.UK)
What this means for your 2026 plan
- Build your strategy in the right order: confirm classification and conformity route, lock the evidence plan (including any clinical investigation timeline), then manage registration and readiness for the April 2026 fee model.
- If you work with hospitals, software, or internally manufactured devices, sanity check whether the Health Institution Exemption logic is being relied on appropriately and document the rationale early.
If you would like a rapid, authority aligned sense check on your classification, regulatory pathway, or submission approach, Assure Regulatory Services (ARS) can support with UK and EU regulatory strategy and execution, dossier and submission delivery, and lifecycle management activities, with broader global support outside EU where needed. Please reach out at info@assureregulatoryservices.com and we will advise the most efficient next step. For further details you can also visit our website www.assureregulatoryservices.com.