UK- Medical Device Requirements:
From 1st Jan 2021 there are several changes to how medical devices are placed in the UK market, one of the requirements include if you are a manufacturer based outside the UK and wish to place a device on the Great Britain market, you will need to appoint a single UK Responsible Person
A written mandate is necessary between manufacturer and UK responsible person. This mandate needs to be submitted to MHRA for registration purpose.
Responsibilities of UK- Responsible Person:
- Device registration with MHRA before placing the device in the UK market.
- Ensure declaration of conformity and technical documentation is present & appropriate conformity assessment procedure has been carried out
- Keep a copy of the technical documentation, declaration of conformity, relevant certificate, including any amendments and supplements for inspection by the MHRA.
- Provide the MHRA with all the information and documentation on request
- Cooperate with the MHRA on any preventive or corrective action taken to eliminate or, if that is not possible, mitigate the risks posed by devices.
- Immediately inform the manufacturer about complaints and reports about suspected incidents related to a device for which they have been designated.
- Terminate the legal relationship with the manufacturer if the manufacturer acts contrary to its obligations under these Regulations and inform the MHRA and, if applicable, the relevant notified body of that termination.
*From 1 Jan 2021 the name and address of the UKRP, where applicable, will need to be included on the product labelling where the UKCA mark has been fixed.
Registrations in Great Britain:
- After the transition period, any medical device, IVD, or custom-made device will need to be registered with the MHRA before being placed on the Great Britain market.
- In Great Britain, devices must conform to the UK MDR 2002, the EU MDR (until 30 June 2023), or the EU IVDR (until 30 June 2023) to be registered with the MHRA.
- This will apply to devices of all classes.
Device Registration Process:
- User needs to create an account with MHRA. The account confirmation is sent by MHRA. After confirmation, user can access the account.
- User i.e. Manufacturer or UK Responsible person (UKRP) must register manufacturer with new application with manufacturer details like company name, address, role, contact information on the MHRA database.
- If UKRP is performing registration on behalf of the manufacturer, then UKRP should also upload the written mandate on the MHRA database.
- After submitting, new device can be added to database. Depending on the device type, device data and CE certificate or self-declaration certificate is asked by MHRA.
- User can preview the application and submit it if all the information is correct.
- Payment needs to be done at the end of the application. Then user have to submit the application to MHRA.
- MHRA responds to application depending on the adequacy of documentation and evidence for safety and performance of the device submitted by the manufacturer or UKRP.
Where any changes to registrations are made, a £100 standard fee will apply per application.
The following devices must be registered with the MHRA if they are being placed on the Great Britain market 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 if they are being placed on the Great Britain market 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 if they are being placed on the Great Britain market from 1 January 2022:
- Class I medical devices
- General IVDs
The following registration data is required for MHRA registration:
- Copy of Declaration of Conformity
- E-copy of technical documentation
- Device Certificate as granted by the Notified Body
- Quality Management Certificate
- Database information Manufacturing details
- Letter of Designation
- Contact persons and list of importers
- Database information Device Details
- Database information Product Details
- Catalog/Reference (REF)
- Unique Device Identification