UK Responsible Person
Brexit News! MDSS-UK RP Ltd. is established!
Ready to support Medical Device Manufacturers located outside the UK.
Trade with the UK will be different when the UK leaves the EU Single Market for good in December 31, 2020.
A UK RP will be required and may be independent of the Importer. Most likely, a contract with an UK RP must be in place by January 1, 2021! See here the latest News & Views.
The UK Responsible Person will need to register the devices with the MHRA and carry out specified tasks on behalf of Medical Device Manufactures located outside the UK.
UK Responsible Person
- Ensure that the declaration of conformity and technical documentation have been drawn up and, where applicable, that an appropriate conformity assessment procedure has been carried out by the manufacturer.
- Keep available a copy of the technical documentation, a copy of the declaration of conformity and, if applicable, a copy of the relevant certificate, including any amendments and supplements for inspection by the MHRA.
- In response to a request from the MHRA, provide the MHRA with all the information and documentation necessary to demonstrate the conformity of a device.
- Forward to the manufacturer any request by the MHRA for samples, or access to a device, and ensure that the MHRA receives the samples or has been given access to the device.
- 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 from healthcare professionals, patients and users 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.
UKCA mark will be required by 2023 and it is expected that the UK RP will need to be on label at the same time.
The different transition timeframes to registering your device from 1 January 2021!
Given that this is an extension of existing registration requirements, there will be a grace period to allow time for compliance with the new registration process.
Until April 31, 2020
- Active implantable medical devices
- Class III medical devices
- Class IIb implantable medical devices
- IVD List A
Until August 31, 2021
- Class IIb non-implantable medical devices
- Class IIa medical devices
- IVD List B
- Self-test IVDs
Until December 31, 2021
- Class I medical devices
- General IVDs
Note that the above 12-month grace period will not apply to manufacturers of Class I devices and general IVDs that are currently required to register with the MHRA.
Registration for custom-made devices will be in line with the risk class of the device. Failure to register by these dates will mean that you will no longer be able to lawfully place your device on the UK market.
Class I devices, custom-made devices and general IVDs being placed on the Northern Ireland market must continue to register as normal as the 12-month grace period will not apply.
Disclaimer: the above is based on the current information received from various sources and from the MHRA directly. However, everything may changed or be more detailed with a new upcoming law.
Special requirements may apply for Northern Ireland.