Overseas manufacturers need a UK Responsible Person now!
Overseas Medical Device and IVD manufacturers selling into the UK market need a UK Responsible Person to meet current regulatory requirements. The good news is that IMed can help ….
When we talk to overseas manufacturers about appointing a UK Responsible Person – many of them believe they dont; need one until the new UKCA rules come into force. So we need to ensure that the message is clear.
Post Brexit, medical device manufacturers based outside the UK, selling or wishing to sell their products in the UK – need to appoint a UK Responsible Person (UKRP), to register their devices with UK MHRA and to act on their behalf with UK Regulators. The UKRP is a new requirement under UK regulations from 1st January 2022. IMed are pleased to now be offering this UK Responsible Person service to overseas clients and are already representing clients from all over the world.
As a UK Responsible Person, IMed will represent overseas manufacturers devices in Great Britain (and Northern Ireland, if required). A UKRP’s duties include;
- ensuring that Technical Documentation and Declaration of Conformity have been properly drawn up
- Holding a copy of current technical documentation
- registering devices with the UK MHRA
- Liaising with UK MHRA on the manufacturer’s behalf with correspondence and compliance matters
Selecting a UK Responsible Person
A manufacturer’s choice of UKRP is an important business decision. Naturally they would want to work with a trusted partner, who can responsibly represent them with UK MHRA.
But it’s also worth considering someone independent of any distribution or import relationships where contracts are already in place. This ensures that manufacturers don’t limit their market access to a single route.
Selecting IMed as your UKRP satisfies both these requirements.
Registration of devices with the UK MHRA
IMed has lots of experience in registering devices with the UK MHRA and can advise manufacturers on the documents and device details required to complete their registrations. We will also register importers’ details, as part of our UK Responsible Person service.
IMed can then continue to advise on the developing quality and regulatory rules in the UK, to ensure that manufacturers can legally sell their devices here and always comply with evolving regulations.
UK or Great Britain?
It’s important to clarify EXACTLY where in the UK devices are being sold, due to Northern Ireland’s unique current regulatory status, so manufacturers need to be specific. Are they selling in Great Britain alone? In Northern Ireland? Or in both?
Different rules apply, depending on their answer;
Selling into Great Britain (England, Scotland & Wales)
To sell medical devices in Great Britain post-Brexit, overseas manufacturers must;
- Have a current, valid CE mark
- Identify and appoint a UK Responsible Person to carry out this registration
Selling devices into Northern Ireland
Sales of medical devices in Northern Ireland are subject to different regulatory requirements than those for placing devices on the market in Great Britain. These are summarised as follows;
- CE marking is required in Northern Ireland; UKCA marking will not be accepted.
- If a manufacturer has a UK Approved Body, and wants to sell into Northern Ireland, but does not intend to sell into the EU or appoint an EU Notified Body, there is a special Northern Ireland specific route which can be used to apply a UKNI marking.
- Most devices will require registration with the UK MHRA.
- All manufacturers outside the UK will need a UK RP.
- An Authorised Representative based in the EU or Northern Ireland must be appointed by manufacturers based outside the EU.
- There are special considerations for manufacturers based in Northern Ireland, which are intended to maintain access to both EU and UK markets – please get in touch to discuss with us your situation.
If you want to clarify if you need a UKRP or find out out more about the UK’s current Regulatory landscape, IMed Consultancy’s Specialist team are always happy to clarify any issues or questions.
Or if you need to appoint a UKRP, please give us a call on 01925 724286 or drop us an email at firstname.lastname@example.org, and we will be delighted to help you.
IMed Business Development Director