A publication released by the MHRA on the 4th January, updated on the 26th February explains how the UK will regulate all medical devices under Directive 90/385/EEC on active implantable medical devices (AIMDD), Directive 93/42/EEC on medical devices (MDD) and Directive 98/79/EC on in vitro diagnostic medical devices (IVDD). Whilst all those devices currently CE marked before the 29th March 2019 under one of these directives will continue to be recognised by the UK for a ‘time-limited period’, one of their criteria is the introduction of a UK Responsible Person for those device manufacturers not established in the UK.
‘Where a device manufacturer is not established in the UK, registration of a product with the MHRA must be undertaken by a ‘UK Responsible Person’ established in the UK and with a UK registered address who will take responsibility for the product in the UK. No labelling changes will be required to reflect the role of this ‘UK Responsible Person’.
The UK Responsible Person will be responsible for ensuring all devices are registered with the MHRA prior to being placed on the UK market. A grace period for registration has been allowed for compliance with the new registration process. The timings are set out as:
4 months, for Class III medical devices, Class IIb implantable medical devices, Active implantable medical devices, IVD List A and procedure packs that contain any of these devices.
8 months, for Class IIb non-implantable medical devices, Class IIa medical devices, IVD List B, Self-test IVDs.
12 months, for Class I medical devices, Self-certified IVDs, Class A IVDs.
The publication then goes onto explain that initially the MHRA will require most products to be registered at the level of Global Medical Device Nomenclature (GMDN) code meaning that groups of similar products can come under a single registration. The exception is class III devices, which must have individual product information registered.
Once the MDR and IVDR fully apply (from May 2020 and May 2022 respectively), the UK will then mirror the new requirements within the legislation, which will mean individual registration of all products
Advena are as usual able to assist all EU (non-UK) and Non-EU device manufacturers to provide a UK Responsible Person via our new ‘UK Responsible Person Service’. Registrations will be performed by our UK office.
Please contact our UK administration team for more information at firstname.lastname@example.org