Register a Medical Device in the UK – A Guide
With the market for medical device expected to reach almost $25bn by 2028 it is not surprising there is significant interest in registering a medical device in the UK. Here’s our guide on how to register a medical device in the UK.
Contents
Registering a medical device in the UK
Manufacturers based outside England, Scotland and Wales.
Manufacturers based in England, Scotland and Wales
Register the medical device with the MHRA
FAQ on Registering Medical Devices in the UK
The process for registering a medical device in the UK depends on a number of factors but a key factor is where the manufacturer is based.
Manufacturers based outside England, Scotland and Wales first need to acquire a UK Authorised Representative (click link to learn how we can help). This is a legal entity based in England, Scotland or Wales that has the knowledge and expertise to register your device on behalf of the non-UK manufacturer.
Manufacturers based in England, Scotland and Wales do not need a UK Authorised Representative.
Regardless of where the manufacturer is based, a thorough compliance check is required because before distributing a medical device within the UK, it is essential to ensure it complies with the current regulations. Any of the following regulations may apply:
The compliance check should be carried out by a trained medical device professional. They will investigate the products characteristics, documentation and instructions for use, among other things. The review will take into account applicable regulations and identify any compliance issues. Provided the device and documentation is compliant with the regulations, the product can be taken to next step: registering the product with the MHRA, the UK regulator for medical devices.
Here are the steps to register a medical device with the MHRA (UK). Remember if you are not based in the UK you must assign a UK Representative to make the registration on your behalf.
Once you submit the registration, the process does not end there. Manufacturers – or the UK Representative – are required to submit vigilance reports to MHRA for any incidents occurring in the UK involving their device. Manufacturers must also take appropriate safety actions when required such as product withdrawals or recalls.
Get in touch to learn more about registering a medical device in the UK and our representative services. Fill in the form below and we’ll get back to you.
Initially, determine the device’s classification according to MHRA rules.
The MHRA charge £240 to register a device. This fee does not include advisory fees or UK Representation fee.
Contact a UK Representative to handle registration and compliance on your behalf.
You must provide a technical file including product details, including brand, model/version, and UDI DI data.
Yes, Great Britain follows UK MDR 2002, while Northern Ireland adheres to EU regulations.
After submission, the MHRA review process timing varies based on device complexity and documentation accuracy.
Unregistered devices cannot be legally marketed or sold in the UK.
The Medicines and Healthcare Products Regulatory authority is the UK body that approves medical devices in the UK.
Get in touch to speak to an advisor today about how to register your medical device in the UK.
We are a London-based regulatory affairs consultancy providing services to the e-cigarette, cosmetic, biocide, pharmaceutical and medical device industry. We help e-cigarette companies comply with the Tobacco Products Directive and pharmaceutical companies obtain and maintain medical product licences. We also offer UKAS accredited biocide and analytical testing services.