International Recognition Procedure for Medical Devices

Back in May the MHRA published a statement of policy intent, outlining the proposal of a new international recognition procedure for medical devices. This comes after its announcement earlier in the year detailing a roadmap for the future new UK medical device regulations, and it’s hoped that this would be implemented by the time this comes into force – currently planned for 2025.? This means that manufacturers of devices may be able to use a reduced route to market where they already have their device approved in another country.

Whilst the UK still currently recognises EU CE marks, this was only a temporary grace which was due to end in 2030. This new framework will put into place what is required to ensure this can continue and also broaden the scope.

By creating a recognition route there is a reduced burden of work, which will ultimately allow for quicker approvals – by working smarter not harder. It reduces duplication and will hopefully enable quicker market access for quality devices to reach the UK market.

There are currently four proposed regulators with which the UK would allow a recognition route – Australia, USA, Canada and the EU. In addition the product must meet certain requirements such as having English language packaging, having a UK responsible person and a unique device identifier. The manufacturer must also still comply with all the UK post market surveillance requirements.

The process would allow for four different routes to market dependent on the current class of the product and how it is currently registered, with those lower class being able to use a self-notification route, and the higher class products using a reliance route where a dossier will need to be submitted to the MHRA.

It is worth noting however that not all devices will be eligible for this route, and there are some excluded classes of devices, for example: Software devices, custom devices, products granted for market access in the CRC via a recognition route, along with others as discussed on the MHRA statement.

We will be keeping an eye out for further announcements on when this process may begin and any other conditions it brings.

Written by Sophie Milden