MHRA Updates Guidance on Legal Requirements for Specific Medical Devices
The Medicines and Healthcare products Regulatory Agency has updated its guidance “Medical devices: legal requirements for specific medical products”, last updated on 20 July 2026.
The guidance provides information for manufacturers on the regulations that apply to prosthetic, orthotic and ophthalmic devices.
The publication applies to England, Scotland and Wales. The MHRA also points readers to a separate publication for Northern Ireland.
Scope of the Guidance
The MHRA guidance explains how manufacturers can comply with the legal requirements applicable to specific medical devices.
According to the document, the guidance covers topics including:
classification;
custom-made prosthetic devices;
custom-made orthotic devices;
custom-made ophthalmic devices;
practical examples.
Relevance for Custom-Made Devices
The guidance is particularly relevant for manufacturers of prosthetic, orthotic and ophthalmic devices that may fall under custom-made device requirements.
Manufacturers should consider whether their products meet the relevant classification and custom-made device criteria, and whether additional compliance obligations apply before placing them on the market.
Impact on Medical Device Manufacturers
For manufacturers of prosthetic, orthotic and ophthalmic devices, the updated guidance reinforces the need to understand the applicable legal requirements before placing products on the market.
Manufacturers should pay particular attention to:
correct device classification;
whether the device is custom-made;
applicable requirements for prosthetic, orthotic and ophthalmic devices;
examples provided by the MHRA;
differences between Great Britain and Northern Ireland requirements;
alignment with wider UK medical device regulatory obligations.
For manufacturers, the guidance highlights the importance of correctly identifying the regulatory status of specific medical devices and maintaining compliance with the applicable UK requirements.
