As we gear up to the potential for a no deal Brexit under the guidance of our new Prime Minister Boris Johnson non-UK manufacturers of in vitro diagnostics (IVD) and medical devices (MD) need to make plans to ensure they can still place IVD devices onto the UK market.
Following guidance by the UK Competent Authority (MHRA) updated 8 August 2019, all non-UK Medical Device and IVD manufacturers must appoint a UK Responsible Person. This is a new role created under the UK MDR 2002 which will apply from the day the UK will leave the EU (31 October 2019).
The UK Responsible Person must be appointed by the manufacturer either by a letter of designation or similar contract, requiring the UK Responsible Person to:
- Register devices within the MHRA DORS system
- Check the availability and hold an up to date copy of the Declaration of Conformity and technical documentation for the device
- Respond to any request from the Secretary of State and provide all the information and documentation necessary to demonstrate the conformity of a device
- Forward to the manufacturer any request by the Secretary of State for samples, or access to a device and ensure that the Secretary of State receives the samples
- cooperate with the Secretary of State 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
IVDeology Ltd have a team of regulatory and quality experts who can act on behalf of non-UK IVD Device and Medical Device manufacturers. We offer a friendly service to help guide manufacturers through the complexities of the UK MDR.
Contact us for more information contact [email protected]