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Considering that the UK MDR 2002 requires to inform the MHRA before you place your devices on the market in Great Britain, note that:
- All medical devices, IVDs and custom-made devices must be registered in MHRA before being placed on the Great Britain market;
- This applies to devices of all classes;
- In Great Britain (England, Wales and Scotland), devices must conform to the UK MDR 2002, the EU MDR (until 30 June 2024), or the EU IVDR (until 30 June 2024) in order to be registered with the MHRA.
Consequently, your UK Responsible Person must register if you or your company sells, leases, lends or gifts:
- Class I, IIa, IIb or III devices you have manufactured;
- Class I, IIa, IIb or III devices you have refurbished or re-labelled with your own name;
- any system or procedure pack containing at least one medical device;
- custom-made devices;
- IVDs you have manufactured;
- IVDs undergoing performance evaluation.
Grace period for registering devices to the MHRA
There is a grace period to allow time for compliance with the new registration process.
The following devices must be registered with the MHRA if they are being placed on the Great Britain market from 1 May 2021:
- Active implantable medical devices;
- Class III medical devices;
- Class IIb implantable medical devices;
- IVD List A products.
The following devices must be registered with the MHRA if they are being placed on the Great Britain market from 1 September 2021:
- Class IIb non-implantable medical devices;
- Class IIa medical devices;
- IVD List B products;
- Self-test IVDs.
The following devices must be registered with the MHRA if they are being placed on the Great Britain market from 1 January 2022:
- Class I medical devices;
- General IVDs
It is possible to register devices ahead of the above dates, but there is no legal obligation to do so. Manufacturers of Class I devices, custom-made devices and general IVDs that, prior to 1 January 2021, were required to register their devices with the MHRA (i.e. where the manufacturer is based in the UK or the Authorised Representative is based in Northern Ireland) must continue to register their devices on the same basis as they they did previously as the above registration timings will not apply to these devices.
It is possible for manufacturers to register devices of different classes, that are subject to different registration dates, at the same time. Example: Obelis UK can register its clients Class IIa medical devices at the same time as registering their Class III medical devices. In this particular case, devices would need to be registered from 1 May 2021 in line with the timings for registering Class III devices.
Labelling
As regards to labelling: devices can have both marks (CE and UKCA) present on the labelling prior to 1 July 2024, and dual marking will continue to be accepted on the Great Britain market after 1 July 2024.
However, the name and address of the UK Responsible Person, where applicable, needs to be included on product labelling where the UKCA mark has been affixed (including when devices have been dual marked).
Would you like to place medical devices on the UK market? Contact us and we will guide you through the process!
Obelis UK is certified according to the international standards ISO 9001:2015 and ISO 13485:2016 for representative and consulting services.
Our regulatory affairs consultants are committed to deliver the most efficient compliance process and support manufacturers to safely place their products on the UK market.
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