UK Responsible Person
MDR (EU) 2017/745
MDD (EU) 93/42/EEC
IVDR (EU) 2017/746
IVDD (EU) 98/79/EC
- 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.
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.
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.