When to Complete MHRA Registration
Where the manufacturer is in the UK or the Authorized Representative is in Northern Ireland, the following devices should be registered with the MHRA presently (no grace period):
- Class I devices
- custom-made devices
- general IVDs
- all IVDs undergoing performance evaluation
- systems and procedure packs
The following devices must be registered with the MHRA from 1 May 2021:
- active implantable medical devices
- Class III medical devices
- Class IIb implantable medical devices
- IVD List A products
The following devices must be registered with the MHRA from 1 September 2021:
- Class IIb non-implantable medical devices
- Class IIa medical devices
- IVD List B products
- self-test IVDs
The following devices must be registered with the MHRA from 1 January 2022 where they have not previously been required to register with the MHRA (manufacturer or Authorized Representative is not based in the UK):
- Class I medical devices
- custom-made devices
- general IVDs
- systems and procedure packs
Information Required for MHRA Medical Device Registration
You are asked to provide the following type of information when registering your devices with us. Please note these lists are non-exhaustive.
Manufacturer details:
- legal entity name and address as it appears on the device labelling/packaging.
- company type e.g. limited company, sole trader.
- administrative contact (you can have up to 15 people with access).
- a letter of designation for UK Responsible Persons (where applicable). This must be a legal contract, stating that you are the exclusive UK Responsible Person acting for the manufacturer and specifying the mandatory tasks you are contracted to undertake on behalf of the manufacturer. The mandatory tasks that must appear in the designation contract can be found in our regulatory guidance for UK Responsible Persons.
Documents for MHRA registration
To complete MHRA device registration, manufacturers must submit a comprehensive set of documents ensuring compliance with UK regulations. Key documents include the Declaration of Conformity, device labels and packaging, detailed device descriptions using GMDN codes, and Basic UDI-DI (if applicable). Manufacturers must also provide conformity assessment certificates or self-certification declarations. For MHRA medical device registration, a letter of designation is mandatory if appointing a UK Responsible Person. Additional information, such as sterility attributes, MRI compatibility, and a valid UK Approved Body certificate (if required), may also be requested. Ensure all documentation is accurate and up-to-date for seamless registration.
MHRA Register of Manufacturers: Details to Provide
- which regulations apply
- the class of device you are registering
- Global Medical Devices Nomenclature(GMDN) code and term to describe your device
- Basic UDI-DI (if applicable)
- medical device name (brand/trade/proprietary name)
- model or version detail
- catalogue/reference number
- UDI-DI (if applicable)
- UK Approved Body (or EU Notified Body) where applicable
- attributes such as sterility, contains latex, MRI compatible
You also need to provide a copy of any conformity assessment certificates or self-certification conformity declarations, as applicable.
How to register in MHRA
- Apply to register on the Device Online Registration System (DORS)
Create MHRA account request by filling details using following link
https://mhrabpm.appiancloud.com/suite/plugins/servlet/registration
- confirmation will come about the account request has been accepted or rejected
- A statutory fee of £100 applies for each registration application
- If you need to update any information within an existing registration, you will be charged a £100 statutory fee.
- Once registered, your company name and address are added to the Public Access Database for Medical Device Registration.
The MHRA registration database contains manufacturer name, address, MHRA reference (account) number, all the devices registered by GMDN term and link is as follows
https://aic.mhra.gov.uk/era/pdr.nsf/name?openpage&start=1&count=200
Renewal of MHRA registration
MHRA Registration must be renewed one year after your registration application or confirmation was made and every two years after this date. If your registration is failed to renew, there will be removal of your records from the MHRA database. After which you need to apply for a new registration or you will no longer be able to place your device on the UK market.
MHRA Registration Importance
MHRA registration is a critical step for medical device and IVD manufacturers aiming to access the UK market. It ensures compliance with UK MDR 2002, verifying that devices meet the safety and performance standards required for public use. Proper MHRA device registration provides legal assurance, allowing manufacturers to sell, lease, or supply their products within the UK. This process, which includes MHRA medical device registration and MHRA product registration, not only establishes market credibility but also protects patient safety. Maintaining up-to-date registrations avoids potential penalties and ensures uninterrupted market access, safeguarding the manufacturer’s reputation and business operations.
