Earlier today the Medicines and Healthcare products Regulatory Agency (MHRA) released updated guidance "Register medical devices to place on the market" and "Export medical devices" documents detailing the procedures for registering medical devices to place on the market and for exporting medical devices from the UK. These documents, effective as of 13 March 2025, provide regulatory clarity for medical device manufacturers and exporters navigating the UK's medical device regulations.
Who Must Register?
All medical devices, including in vitro diagnostic devices (IVDs), custom-made devices, and systems or procedure packs, must be registered with the MHRA before they can be placed on the market in Great Britain (England, Wales, and Scotland).
When to Register?
Devices must be registered before they are placed on the market in Great Britain. It's essential to ensure that all information registered with the MHRA is accurate and current.
Information Required for Registration
When registering devices with the MHRA, the following information is typically required:
Manufacturer Details: Name, address, and contact information.
Device Details: Description, classification, and intended purpose.
Conformity Assessment: Evidence of conformity with applicable regulations, such as the UKCA mark.
How to Register
Registrations are made through the Device Online Registration System (DORS).
Steps:
Create an Account: Access the DORS platform and create an account.
Submit Information: Provide all necessary details about the manufacturer and the device.
Review and Confirmation: Ensure all information is accurate before submission.
Fees
There are fees associated with the registration of medical devices. It's advisable to consult the latest MHRA guidelines for the most current fee structure.
References:
A Certificate of Free Sale (CFS) may be required to export medical devices outside the UK. This certificate confirms that the devices are legally sold or distributed in the open market, without restrictions, and is often requested by foreign authorities.
Certificates of Free Sale
A CFS should not be taken as a government endorsement of any product referred to on the certificate.
The MHRA does not assess or verify that the product complies with relevant export requirements and restrictions when issuing a CFS. It is the applicant’s responsibility to ensure compliance with these requirements and regulations.
Types of CFS Issued:
For Great Britain (England, Wales, and Scotland): A CFS for the UKCA mark stating that the medical device can be freely sold on the Great Britain market.
For Northern Ireland manufacturers or Northern Ireland-based Authorised Representatives: A CFS for CE-marked devices, stating they can be sold freely in the UK and EEA. If the device is CE UKNI marked, the CFS will state that it can be freely sold in the UK only.
These MHRA certificates are issued as PDF documents with an electronic signature.
Note: The Foreign, Commonwealth & Development Office will not apostille PDF documents directly from the MHRA. You will need a Notary who will carry out checks on the certificate before it can be apostilled.
Before You Apply
Eligibility Criteria:
A CFS can only be ordered for medical devices and IVDs that have been registered with the MHRA on the DORS.
In vitro diagnostic medical devices for performance evaluation cannot be included in CFS orders.
A CFS can only be ordered by a UK-based manufacturer, UK Responsible Person, or Northern Ireland-based Authorised Representative.
Evidence must be provided that the medical devices have relevant conformity assessment marks (UKCA, CE, CE UKNI) to show compliance with the UK Medical Devices Regulations 2002 (as amended).
How to Apply
Steps:
Access the MHRA Portal: Use the MHRA's online system to apply for a CFS.
Provide Necessary Documentation: Ensure all required documents and evidence of conformity assessment marks are ready for submission.
Submit Application: Complete the application process through the portal.
Fees
Fees are associated with obtaining a CFS. It's recommended to consult the latest MHRA guidelines for the current fee structure.
Processing Time
The time taken to process a CFS application can vary. Applicants should plan accordingly and consult the MHRA for estimated processing times.
References:
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