As of January 1st, 2021, Medical Devices that are put on the UK market will be regulated under the UK MDR 2002 and non-UK manufacturers have to appoint a UK Responsible Person, analogue to the Authorized Representative in the EU.
It’s our pleasure to inform you that our sister company in the UK -UKCApartner4U- is able to provide these services. They will do so in close collaboration with CEpartner4U, ensuring the same quality level.
We’re available for any questions you may have and if you would like to receive additional information concerning this new UK requirement please do not hesitate to contact us.
Ton Pennings, Director
Also in the UK we’re there for 4U!
Responsibilities of the UK Responsible Person
- Register devices with the MHRA
- 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.
- Provide samples of a device to the MHRA or allow the MHRA access to the device where the UK Responsible Person has samples or access or, where they do not have access or samples, forward to the manufacturer any request from the MHRA for samples or access.
- 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.
For now, UK market access is based on the MDD. You may place CE marked devices on the UK market until the 1st of July 2023. After that, the UKCA mark is mandatory.
All devices will need to be registered with the MHRA from 1st Jan 2021, with following grace periods:
To be registered by 1st May 2021;
- Active Implantable Medical Devices
- Class III Medical Devices
- Class IIb Implantable Medical Devices
- List A IVDs
To be registered by 1st September 2021;
- Class IIb Non-Implantable Medical Devices
- Class IIa Medical Devices
- List B IVDs
- Self-Test IVDs
To be registered by 1st January 2022;
- Class I Medical Devices
- General IVDs
Market access in Northern Ireland (NI) differs from the UK. Please contact us for the specific NI requirements if necessary.
Source: Regulating medical devices from 1 January 2021 (https://www.gov.uk/guidance/regulating-medical-devices-from-1-january-2021)