The MHRA published the UK Statement of policy intent: international recognition of medical devices on 21 May 2024, it provides more details of their intensions for reliance and recognition initially described in the UK governments response to the 2021 consultation on the future regulation of medical devices in the UK.
This is a short summary of the article, you have the option to download a more detailed article at the bottom by leaving your details.
The devil is always in the detail, and there is a lot of detail. This is a Policy so we will have to wait until the end of 2024 to see the text of the UK Core regulation. It is also important to note that the UK announced a General Election on 4th July, this means that the MHRA as part of the civil service is not able to provide any comments until the election is over. There is also a risk that the new government could take a different approach; however, discussions in the lead up to the election suggest that there is unlikely to be radical change; however, it remains a risk.
The aim of proposed policy is to recognise the work conducted in other regions and strike a balance between public safety and speed of access to the UK market to ensure that device remain available on the UK market. There is a trend amongst global regulators to consider reliance and recognition models to prevent duplication of effort. Australia and Singapore have already adopted these models.
The World Health Organisation used the following definitions,
Recognition
Acceptance of the regulatory decision of another regulator or trusted institution.
Reliance
The regulatory authority in one jurisdiction takes into account assessments performed by another regulatory authority reaching its own decision.
There are 4 proposed routes in the Policy, this table summarises the options.
This Policy is not a simple recognition model where registration is the only additional requirement. There are additional requirements for all devices and exclusions for each of the routes, so it is important to read the detail.
There is no immediate action needed, but it's good to review your strategy even if you can't take action. Qserve will follow the communications and will update you with regard to any actions needed to comply with these future UK medical Device Regulations. If you have any substantive questions about your device, please send them to info@qservegroup.com.
Qserve has prepared a more detailed analysis based on our review and discussion with other stakeholders in the UK. Please leave your details to download the full article.