Main Facts about the new UK requirements
Trade with the UK will be different when the UK leaves the EU Single Market on December 31, 2020
A UK RP (Responsible Person) will be required if the Manufacturer is not located in UK and may be independent of the Importer located in the UK.
The UK RP (Responsible Person) will need to register the devices with the MHRA and carry out specified tasks on behalf of Medical Device Manufacturers located outside the UK.
UK Responsible Person Tasks
- 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.
Labelling requirements
UKCA mark will be required by 2023.
It is expected that the UK RP and CE mark will need to be on label at the same time.
The above picture shows how your label will have to look like to be in compliance with the UK requirements.
We would not recommend to do any update on the labels for now as there isn’t an official UKRP symbol yet. Someone could argue that your label is not in compliance because you are not using the approved symbol.
Timeline to register your devices
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. For UK clients, class I and general IVDs, the registration must continue.
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.
Disclaimer
The above is based on of the latest Regulation – the Medical Devices (Amendment etc.) (EU exit) Regulations 2020- and Guidance documents given by the MHRA as at the date hereof.
Special requirements may apply for Northern Irland.
