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.
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 Irland.