IMed launches UKRP Services for Manufacturers outside UK

by | Jul 14, 2021 | IMed Consultancy, MDR, UKRP | 0 comments

Brexit EU UK Trade

Do you need a UK Responsible Person to meet your UK regulatory requirements? If you do – or even if you aren’t sure if you do, IMed can help.

Post Brexit, medical device manufacturers based outside the UK, selling or wishing to sell their products in the UK – will need to appoint a UK Responsible Person (UKRP) from 2021, to act on their behalf with UK Regulators. The UKRP is a new requirement under UK regulations. IMed are pleased to now be offering this UK Responsible Person service to clients.

As a UKRP, IMed will take responsibility for manufacturers devices in Great Britain (and Northern Ireland, if applicable). A UKRP’s duties include registering devices with the UK MHRA, liaising with them on the manufacturer’s behalf and ensuring that Declarations of Conformity and technical documentation have been properly drawn up.

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. They may also wish to use someone independent of any distribution or import relationships and contracts already in place. So, selecting IMed as their UKRP ticks both of these boxes.

Registration of devices with the UK MHRA

IMed has plenty 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 on their behalf, 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, manufacturers must;

  1. Have a current, valid CE mark
  2. Meet the device registration deadline with the UK MHRA, which is a critical new obligation
  3. Manufacturers outside the UK must identify and appoint a UK Responsible Person – who must carry out this registration well before their devices’ registration deadline.
  4. Prepare to meet UKCA requirements by 01 July 2023?

IMed are delighted to be able to assist with all of these aspects of regulatory compliance as a UK RP.

Device Registration Deadlines

Post Brexit – manufacturers are allowed continue to sell their devices in Great Britain under a current valid CE mark until 30 June 2023, but the device must be registered with MHRA, subject to the following deadlines;

Device Types

Registration Deadline

Comments

IVDs undergoing performance evaluation (new studies)

Immediate – no grace period

 
Active implantable medical devices
Class III medical devices
Class IIb implantable medical devices
IVD List A products

1 May 2021

This deadline has passed – all these devices must now be registered to be sold in Great Britain

Class IIb non-implantable medical devices
Class IIa medical devices
IVD List B products
Self-test IVDs

1 September 2021

 

Class I medical devices

General IVDs

1 January 2022

The grace period does not apply for these devices where the manufacturer or the Authorised Representative is based in the UK as such devices were previously required to be registered with the UK MHRA.

Custom-made devices

In line with grace period for risk class of device

Systems and procedure packs

In line with grace period for device with highest risk within the system/pack

If your device’s deadline has passed and you need to register your device urgently, please contact IMed immediately on 01295 724286 and we will assist you.

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, which can appear confusing. These are summarised as follows;

  • CE marking is required in Northern Ireland, and UKCA marking will not be accepted
  • Most devices will require registration with the UK MHRA, but there are some differences in requirements, where devices are placed only on the Northern Ireland market, and not in Great Britain
  • Most manufacturers outside the UK will need a UK RP, but there are some exceptions
  • An Authorised Representative based in the EU or Northern Ireland must be appointed by manufacturers based outside the EU (this includes those based in Great Britain, but is not applicable to manufacturers based in Northern Ireland)
  • Manufacturers from Northern Ireland, who CE mark their device, will be able to continue to place such CE marked devices on the Great Britain market after 30 June 2023, without obtaining a UKCA mark.

If you want to know more about UKRPs and their role in the new 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 hello@imedconsultancy.com, and we will be sure to help you.

Kate Bandy

Kate Bandy

IMed QA/RA Consultant