As the UK continues to upgrade its post-Brexit regulatory landscape, understanding the medical device registration process under the UK Medical Devices Regulations 2002 (UK MDR 2002) is essential for manufacturers, importers, and regulatory professionals aiming to access the Great Britain (GB) market.
This blog outlines the step-by-step process for registering medical devices with the Medicines and Healthcare products Regulatory Agency (MHRA)—including key timelines, roles, and compliance expectations.
Who Must Register?
All medical devices, like in vitro devices (IVDs), custom-made devices, and procedure packs, must be registered with the MHRA before they can be sold in Great Britain (England, Wales, and Scotland).
Selling Devices in Great Britain
According to the UK MDR 2002, one must notify the MHRA before selling device in Great Britain. One need to register if they or their company:
All medical devices, including in vitro diagnostic devices (IVDs), custom-made devices, and procedure packs, must be registered with the MHRA before being sold in Great Britain.
Custom-made devices that followed the EU Medical Devices Directive (EU MDD) or the EU Active Implantable Medical Devices Directive (AIMDD) can no longer be sold in Great Britain. However, one can register their custom-made device under UK MDR 2002 Part II or Part III, which currently aligns with EU rules. A proper custom-made statement must accompany the registration.
Since January 1, 2021, non-UK manufacturers must have a UK Responsible Person to register their devices for the Great Britain market. An Authorized Representative based in Northern Ireland cannot register devices for the Great Britain market anymore.
If one does not register their devices, they cannot legally sell them in Great Britain.
Information Needed to Register Medical Devices with the MHRA
When one registers their devices, the following information must be provided.
Manufacturer Information:
The letter for UK Responsible Persons must be a legal document stating that they are the exclusive UK Responsible Person for the manufacturer. It should describe the required tasks the UK Responsible Person will perform for them.
Device Information:
One must also need to provide copies of any conformity assessment certificates or self-certification declarations, if applicable.
Note: This list may not cover everything, and MHRA might ask for more details during their review process.
Device Online Registration System (DORS) Overview
To register medical devices, first an account on the MHRA DORS need to be created. After the registration an email will be received confirming whether the account request is accepted or rejected.
It will not be officially registered until the details of device and confirmation is received. It is very important to ensure all information is accurate and up to date. The MHRA may ask for additional technical documents to verify compliance with regulations before finalizing the registration.
Registering with the MHRA does not mean the device is accredited or approved. One should not claim otherwise or use MHRA logos in marketing materials or packaging.
Fees:
100 devices and a total of 20,000 products could be registered in one application. Changing information in an existing registration may require additional fees.
Reviewing The Registration:
Regularly check the registration to keep it current. One must inform the MHRA of any changes as per legal requirements. A renewal process will remind the user to update their registration; the first renewal is due one year after the account is created.
Failure to renew may lead to account suspension, preventing the manufacturer from adding new devices or ordering certificates.
Updating Organization Details:
To update organization details or add new devices, follow the instructions in the Account management reference guide. Fees apply for these changes. If no changes are needed, there is no fee for the review.
Making Changes:
Log into the DORS to update your information. If registered before July 1, 2018, and the registration number starts with ‘CA’ or ‘IVD’, it will need to re-register the details on the DORS.
Public Register of Manufacturers
After registration, the company name, address, and types of medical devices it will be added to the Public Access Registration Database (PARD).
Records include:
Please note that in vitro diagnostic medical devices undergoing performance evaluation studies will not be shown in this database.
The MHRA describes devices and their classifications according to the International Medical Device Regulators Forum (IMDRF).
Currently, brand, trade, or proprietary names of registered devices are not displayed on PARD.
If one’s registration isn’t showing on PARD, or if their devices are listed as 'Devices pending update by manufacturer,' please log in to one’s account and update their registration as needed.
Implement Post-Market Surveillance (PMS)
In 2024, the government put in place legislation to clarify and strengthen the post-market surveillance (PMS) requirements for medical devices in use in Great Britain. The Medical Devices (Post-market Surveillance requirements) (Amendment) Great Britain) Regulations 2024 will come into force on 16 June 2025. Under PMS-
Need help navigating UK regulations?
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