All medical devices sold in the UK MUST now be registered with MHRA
All medical devices sold in the UK MUST now be registered with MHRA
It’s a new year, with a new regulatory change to consider. The final legal registration deadline for both medical devices and IVD’s in the UK was 31 December 2021, so all products being sold into the UK must now be registered with MHRA.
If a manufacturer has not yet performed their registration, this brief guide will help you understand how to perform the registration.
Manufacturers Based Outside of the UK
Registration for manufacturers based outside of the UK must be performed by a “UK Responsible Person”(UK RP), which is a similar role to that of an EU Authorized Representative. The manufacturer is responsible for appointing their UK RP. In some cases, this can be a UK subsidiary of the manufacturer, a UK distributor, or an independent regulatory consultancy who is qualified and registered as a UK RP.
Please be aware that where the UK Responsible Person is also a distributor, they have obligations to register any additional importers, so this could potentially create barriers as your other distributors could be their competitors – and if they refuse to perform this task, then there could be difficulties for the manufacturer with other markets or products. A manufacturer may only have a single UK RP for all of its products.
When appointing the UK Responsible Person the manufacturer should consider that;
- the UK Responsible Person is required to have access to the full technical documentation for products it registers. So, is this information suitable to send to your supply chain partners?
- the UK Responsible Person is responsible for registration of Importers. If choosing a distributor to be your UK RP, could this create barriers to other routes to market, or for your other other products, as manufacturer, if your UK RP Distributor refuses to register your other distributors, either now or in the future?
IMed has supported many manufacturers as their UK RP, and remains independent of product supply chains – which enables manufacturers based outside the UK to ensure their registrations are managed and maintained without commercial impact AND with full confidentiality of sensitive technical information ensured.
UK Based Manufacturers
Registration for UK based manufacturers can be performed directly by the manufacturer with MHRA.
The manufacturer will need to register for or use an existing MHRA Device Online Registration System (DORS) login, MHRA guidance on registration is available on the following link;
If UK based manufacturers require support in performing registrations, IMed have a wealth of experience in using the MHRA systems and can provide training or support to UK based manufacturers in use of the MHRA system, including compiling and performing the registration.
Just get in touch with us on 01295 724286 or by email to hello@imedconsultancy.com if you need any help.
Tim Bubb
Technical Director