How to register a medical device in UK

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.

Registering a medical device 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.

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

Manufacturers based in England, Scotland and Wales do not need a UK Authorised Representative.

Compliance Check

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:

• UK Medical Devices Regulations 2002
• Medical Devices (Amendment) (Great Britain) Regulations 2023
• EU Medical Devices Directive (93/42/EEC)
• EU Medical Devices Regulation (2017/745)

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.

Register the medical device with the MHRA

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.

1. Create an MHRA Account: Head to the MHRA website and create an account on the ‘DORS’ (Device Online Registration System). Before creating an account you must first apply to register for a DORS account.
2. Log into DORS: Use the username and temporary password to log into the DORS system. You will be prompted to change your password upon first login.
3. Register Your Device: Once logged in, you can start the registration process for your medical device. This includes providing detailed information about the device, such as the device type, classification, and intended use.
4. Pay the Registration Fee: The fee for registrations is £240 per application. 
5. Submit Your Application: After completing all necessary fields and uploading required documents, submit the application for review by the MHRA.

Maintenance of Registration

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.

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