6th August 2021
Medical devices regulation in the EU is changing, but what does it mean in the post-Brexit world?
In this briefing, Walker Morris Regulatory & Compliance expert Claire Burrows considers the current state of play, summarises the government’s guidance for manufacturers placing medical devices on the UK and EU markets, and highlights recent regulatory changes concerning coronavirus test devices.
As we reported in our earlier briefing, full implementation of the EU Medical Devices Regulation (MDR) was delayed by a year to 26 May 2021 due to the pandemic. This means that the MDR and the EU in vitro Diagnostic Medical Devices Regulation (IVDR), which takes full effect in the EU from 26 May 2022, will not be implemented in Great Britain because the Brexit transition period has ended. They will apply in Northern Ireland.
The current UK system under the Medical Devices Regulations 2002 (the Regulations) still derives from pieces of EU legislation, the predecessors to the MDR and IVDR. As the European Commission explains, the MDR adds new requirements and is generally more stringent, especially in terms of risk classes and the oversight provided by Notified Bodies. There is also more emphasis on a life-cycle approach to safety, backed up by clinical data and post-market monitoring.
Going forward, a new Medicines and Medical Devices Act (the Act) passed in February 2021 paves the way for the UK to create a ‘robust, world-leading regulatory regime for medical devices that prioritises patient safety’. The government says it will take into consideration international standards and global harmonisation in the development of the future system, which is expected to go out to public consultation this summer.
Aside from the powers contained within it to amend the existing regulatory framework, the Act consolidates the enforcement regime for medical devices and provides the Secretary of State with the ability to impose civil sanctions (such as monetary penalties) as an alternative to criminal prosecution and powers to share information about medical devices. It also introduces a new role of Commissioner for Patient Safety.
Against a backdrop of ageing populations and rapid advances in technology, the medical device sector is ripe for investment. In his response to the Delivery Plan recently published by the Medicines and Healthcare products Regulatory Agency (MHRA), the Innovation Minister talked about how the UK will grasp the opportunity of innovation now we have left the EU.
While the move away from the EU provides the UK with flexibility and the ability to focus on its global role, there are concerns that any plans to diverge from EU standards could have a chilling effect on the UK’s global innovation ambitions, put investors off, and subject UK businesses (heavily reliant on EU exports and therefore already compliant with EU standards) to unnecessary red tape and expense under a separate national regulatory regime.
Walker Morris will continue to monitor and report on developments as the situation evolves.
The Commission has produced a factsheet for medical device manufacturers which explains the MDR in more detail. Key points are:
Obligations on manufacturers include:
The Regulations were recently amended  to require coronavirus test devices to be approved by the Secretary of State before they are placed on the market, put into service or supplied, with certain exceptions. The changes came into force on 28 July 2021 but will not apply to devices placed on the market before 1 September 2021. There is a transitional period between 1 September and 31 October 2021 during which such devices may be placed on the market if an application has been made to the Secretary of State, or the person placing it on the market is not the manufacturer or a person acting as their UK Responsible Person. The standard application fee is £14,000. This is reduced to £6,200 for small/medium sized enterprises (less than 250 employees).
If you have any queries or require any advice or assistance in relation to any of the points covered in this briefing, please contact Claire, who will be very happy to help.
 1 May 2021 for Class III and Class IIb implantables, and all active implantable medical devices and in vitro diagnostic medical device (IVD) List A products; 1 September 2021 for other Class IIb and all Class IIa devices and IVD List B products and Self-Test IVDs; and 1 January 2022 for Class I devices, custom-made devices and general IVDs that do not currently need to be registered (manufacturers that were required before 1 January 2021 to register those devices must continue to do so from that date).
 Class I medical devices that are sterile or have a measuring function require UK Approved Body approval first.
 By The Medical Devices (Coronavirus Test Device Approvals) (Amendment) Regulations 2021.