Following Britain’s exit from the EU, all non-UK medical device and IVD manufacturers who want to place their products on the UK market must appoint a ‘Responsible Person’ (UKRP) to register and act on their behalf with the MHRA.
All change in UK medical device and IVDR regulation
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”
What are the responsibilities of the UK Responsible Person?
The MHRA guidelines define the responsibilities of the UKRP in the following way:
- To register any new and existing devices their client wishes to market in the UK with the MHRA
- Ensure that their declaration of conformity and technical documentation are in place and accessible
- Make available a copy of required technical documentation including a copy of the declaration of conformity and relevant certification.
- Provide the MHRA with all the information and documentation necessary to demonstrate the conformity of a device if/when requested.
- Forward to the manufacturer any request by the MHRA for samples, or access to the developed device. It is then up to the UKRP to ensure that the MHRA receives the samples or has been given access to the device.
- Report on post-market surveillance The manufacturer/UKRP must have a system in place for immediately informing the manufacturer about complaints and reports from healthcare professionals, patients and users about suspected incidents related to a device.
- Cooperate with the MHRA on any preventive or corrective action taken to eliminate an issue or, if that is not possible, mitigate the risks posed by devices.
- Terminate the legal relationship with the manufacturer if the manufacturer acts contrary to its obligations under these regulations and inform the MHRA and, if applicable, the relevant notified body of that termination.
What are the deadlines for the UKRP to register medical and IVD devices with the MHRA?
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:
- Active implantable medical devices
- Class III medical devices
- Class IIb implantable medical devices
- IVD List A products
From 1 September 2021:
- Class IIb non-implantable medical devices
- Class IIa medical devices
- IVD List B products
- Self-test IVDs
From 1 January 2022:
- Class I medical devices
- General IVDs
What will you need to register your devices with the MHRA?
A formal ‘letter of designation’
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.
Avoiding obstacles to successful 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.
How can non-UK manufacturers prepare for an uncertain post-Brexit future?
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.
Find a trusted UKRP
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.
Pick your tech partners carefully
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:
- Respond to MHRA questions with links to technical documentation
- Be alerted when complaints and incidents arise with the product
- Report on corrective and preventive action raised in response to issues and complaints
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.