Today the MHRA has published its guidance on Regulating Medical Devices from 1st January 2021

This will bring significant changes to the way IVDs are placed on market in Great Britain.

https://www.gov.uk/guidance/regulating-medical-devices-from-1-january-2021

One significant change from 1st January 2021 is the need for non-UK based manufacturers to utilise a UK Responsible Person.

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.

We will provide further analysis of the new guidance in the coming days

– the IVDeology team