Get regulatory advice from MHRA — Medical Devices

4th December 2025

Get regulatory advice from MHRA — Medical Devices

Summary:

• Before placing a medical device on the market (or carrying out a clinical investigation), you can request a regulatory advice meeting with MHRA — for example, to clarify conformity assessment, classification, clinical-investigation requirements or post-market obligations. 

• This service helps you navigate the UK regulatory framework, including requirements under the current UK Medical Devices Regulations, device registration, UKCA marking, and other legal or compliance matters. 

• The advice can be particularly valuable when your device involves novel technology (e.g. software, AI, combined products) or when you are unsure about classification or conformity requirements under the revised regulatory regime.

• MHRA’s regulatory advice is not a guarantee of approval, but a consultation to guide you and reduce regulatory risk.

• Relevant guidance documents and regulations are referenced to support the advice, and the page links to other guidance collections (e.g. “Regulating medical devices in the UK”). 

Link: Medical devices: get regulatory advice from the MHRA

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