Brexit is fundamentally changing the way medical devices and IVDs are regulated in the UK. From now on the market will be subject only to legislation created by the UK government and regulated solely by the UK body, the MHRA. In the future, manufacturers of medical and IVD devices will need approval for their products from a UK Competent Authority and apply a UKCA marking to legally trade here.
There is also a new obligation for non-UK manufacturers to appoint a Responsible Person to deal with the MHRA on their behalf. A UKRP is defined as:
“a person established in the United Kingdom who acts on behalf of a manufacturer established outside the United Kingdom in relation to specified tasks with regard to the manufacturer’s obligations under these regulations”
The MHRA guidelines define the responsibilities of the UKRP in the following way:
One of the first jobs of the UK responsible person is to register the devices their partner sells (or wish to sell) into the UK market with the MHRA. Some of the deadlines for registration of existing devices have already passed, but the final deadline for remaining classes of devices to be registered is coming up on 1st January 2022.
The timetable for registering existing/new devices has been set out by the MHR as follows:
From 1 May 2021:
From 1 September 2021:
From 1 January 2022:
You need to formally appoint your UKRP in a headed letter of designation which states the company name and address for both the overseas manufacturer and the UK Responsible Person.
This document must state that the UK Responsible Person is acting with the consent of the overseas manufacturer and adheres to the legislation that applies for the devices being placed on the UK market.
This needs to be signed by both parties and then provided to the MHRA as part of device registration.
Our friends and colleagues at IVDeology have outlined some of the potential obstacles for smooth device registration.
They stress how important it is for the UKRP to list the Global Medical Device Nomenclature (GMDN code) of all the devices their client wishes to register when they make their declaration to the MHRA. Without the GMDN code the registration of the device could be rejected altogether.
Stuart Angell at IVD also encourages manufacturers to ensure device names and reference codes are consistent with what appears on other official documents, including “labels, DOC and EC certificates.”
It seems discrepancies in these details have caused delays or rejected registrations as businesses have begun to respond to the new requirements in recent months.
The UKRP is a new requirement for a new regulatory system in the UK - and businesses are still feeling their way in their work with them. But there are many other unknowns in the road ahead as the UK government tries to figure out the future shape of the UKCA process for med devices.
Right now, UKCA mark requirements are based on the requirements of the EU directives currently enshrined in UK law through the UK MDR 2002. But these are likely to change as the UK creates their own regulatory framework.
For non-UK manufacturers negotiating this complexity, the urgency of finding a reliable UKRP is clear. They will be a required point of contact for the MHRA, supplying them with information on demand and ensuring they remain compliant with the regulation as it is defined and evolves. They will be a vital link in the supply chain and the only way non-UK developers can communicate with the regulator. So, the more expertise and experience they have in dealing with the MHRA, the better.
But working with other partners on the ground in the UK who can provide Quality Management and compliance tools could also be vital to the smooth transition to a new UK regulatory landscape, too.
Medical device and IVD manufacturers need the flexible, electronic Quality Management Systems (eQMS) that can help them effectively organise their documentation to demonstrate compliance with regulations. They need to make these systems easily available to their UKRP who can use them to:
Being able to give a third party ‘responsible person’ secure, yet carefully controlled access to a cloud based eQMS to furnish the MHRA with required documentation is essential. They will need access to the detail of the quality systems, design history and post-market surveillance data for your product, but not given unfettered access to every part of your business IP.
Manufacturers not used to working in this way with third parties will do well to consider what systems they will need to share information with them seamlessly and securely.
In the wake of Brexit, the British government has promised they will carve out a new regulatory environment that will make the UK an ‘attractive’ place for medical and IVD developers to do business. Indeed, James Bethell, the health department’s innovation minister, said in July the new regulation being developed is designed to “grasp the opportunity for innovation now we have left the EU”.
As these new developments play out, non-UK manufacturers are going to need a range of dependable compliance partners and representatives on the ground to help them respond to rapidly evolving regulation in a changing marketplace.