Medical device manufacturers selling in the UK have new responsibilities post-Brexit. Will you be registered and represented in time for the 2021 UK MHRA Registration deadlines?
Shutterstock
If you sell your medical device in the UK, you should be aware that your responsibilities as a manufacturer have changed following Brexit. You probably know that if you have a CE mark, it will continue to be recognised within Great Britain for medical devices and IVDs until 30 June 2023 (the UKCA mark deadline being 1 July 2023). But that’s not it; you have other immediate steps to take in 2021, to ensure you can still sell your CE-marked device legally in the UK until then.
All medical device manufacturers wanting to continue to sell in the UK, using the interim recognition of their CE mark until the 30 June 2023 deadline, must also
- appoint a UK Responsible Person (UKRP), if you are based outside the UK
- register your medical device/IVD with the UK Medicines and Healthcare products Regulatory Agency (MHRA) well before your device’s classification deadline
- become conversant with your future regulatory requirements for UKCA marking from 1 July 2023 and start preparing.
Exactly what conformity assessment requirements apply when?
Until 30 June 2023, devices can be placed on the Great Britain market if they are CE marked in accordance with, EU AIMDD (Directive 90/385/EEC), EU MDD (Directive 93/42/EEC), EU IVDD (Directive 98/79/EC), EU MDR (Regulation 2017/745) and EU IVDR (Regulation 2017/746).
From 1 July 2023, all medical devices and IVDs to be sold in Great Britain will need a UKCA mark.
There is one exception to the UKCA requirement for medical devices produced by manufacturers based in Northern Ireland, who will be able to continue placing CE-marked devices on the market in Great Britain after 1 July 2023.
UK Responsible Person
Overseas manufacturers will have to appoint a UKRP based in the UK to act on their behalf. UKRPs have a key role in acting as a point of contact for the MHRA, and for registering the devices with them. Further obligations include
• ensuring that Technical Documentation and the Declaration of Conformity have been properly drawn up
• informing the manufacturer of any complaints or reports of suspected incidents that occur within the UK.
Some manufacturers don’t realise that this requirement for a UKRP already exists. But any manufacturer, based outside the UK, must have one to even register their device with the MHRA. Under the new rules, overseas manufacturers must
• select a suitable UKRP
• put in place a written letter of designation with their chosen UKRP
• provide the UKRP with all appropriate product documentation
• advise their UKRP of the details of the importers of their products
• ensure that the UKRP registers their product correctly and before its classification deadline.
Registration deadlines
The UK Regulatory Authorities have offered manufacturers some grace periods for the transition. The deadlines for each classification are indicated in Table I.
Table I: The deadlines for each classification.
Importantly, for Northern Ireland manufacturers or for selling devices in Northern Ireland, please check MHRA guidance, as rules can differ.
Device labelling
If manufacturers are CE-marking devices under relevant European legislation, then there is no requirement to add the UKRP to their labelling at present. Such changes are not required until they make the transition to a UKCA mark (from 1 July 2023 latest). At that point, the address of the UKRP must appear on device labelling, in addition to the UKCA mark itself.
Summary
From 1 July 2023, all medical devices/IVDs placed on the Great Britain market must comply with UKCA requirements, including labelling requirements. Prior to 1 July 2023, UKCA marking is voluntary, but manufacturers are urged to transition in plenty of time. And, where devices require review by a UK Approved Body, long lead times are anticipated, so early submission is advisable. UKRPs for all products currently sold in the UK, however, should already be appointed.