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Medical devices regulation UK/EU: What businesses need to know

sterilization-of-medical-instruments Print publication

06/08/2021

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.

The post-Brexit future for medical 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 EU system – requirements

  • CE marking is required to demonstrate compliance with the relevant EU legislation. The UKCA mark (see below) is not recognised on the EU market.
  • EU-recognised Notified Bodies must be used to conduct third party conformity assessments.
  • Devices placed on the EU market before 1 January 2021 can stay on the market.

The Commission has produced a factsheet for medical device manufacturers which explains the MDR in more detail. Key points are:

  • The MDR reclassifies certain devices and has a wider scope. For example, it explicitly covers all devices for cleaning, sterilising or disinfecting other medical devices; reprocessed single-use medical devices; and certain devices with no intended medical purpose. Manufacturers will need to check their products to determine whether devices (including software falling within the definition of ‘medical device’) will be reclassified or will need to be scrutinised by a Notified Body. Determining the risk class of a medical device is essential in specifying the steps required for CE marking, especially regarding the choice of conformity assessment procedure and clinical requirements.
  • There is a new clinical evaluation consultation procedure for some Class IIb devices and for implantable Class III devices by an independent expert panel.
  • There are more stringent requirements for the designation of Notified Bodies, with increased control and monitoring.
  • A new Unique Device Identification system will significantly enhance the traceability and the effectiveness of post-market safety-related activities.
  • There will be increased transparency, with information on devices and studies being made public.
  • The MDR also covers internet sales of medical devices and medical devices used for diagnostic or therapeutic services offered at a distance.

Obligations on manufacturers include:

  • Having systems for risk management and quality management.
  • Conducting clinical evaluations.
  • Compiling technical documentation.
  • Applying a conformity assessment procedure.
  • Responsibility for their devices once they are on the market, including having systems to cover financial responsibility for harm caused by defective devices.
  • Having a named person responsible for regulatory compliance.
  • Providing an implant card for the patient in relation to some implantable devices.
  • Drawing up a declaration of conformity.
  • Applying CE marking to their devices.
  • Having a contract with an authorised representative inside the EU/European Economic Area (EEA) if not established in the EU/EEA.

The UK system – requirements

  • Different rules apply in Great Britain and Northern Ireland. The bullet points below concern the GB market. Please contact Claire if you need advice or assistance on placing medical devices on the Northern Ireland market. Broadly, devices placed on that market must comply with EU legislation.
  • Since 1 January 2021, all medical devices placed on the GB market need to be registered with the MHRA. Various grace periods apply [1].
  • Non-UK established manufacturers must appoint a UK Responsible Person to register and act on their behalf. This could be an importer or distributor. Where the GB importer does not fulfil this role, they must inform the UK Responsible Person of their intention to import a device. The UK Responsible Person must provide the MHRA with a list of importers.
  • The manufacturer (or their UK Responsible Person) must have a registered place of business in the UK.
  • Medical device manufacturers must comply with relevant product marking and conformity assessment requirements.
  • From 1 July 2023, a UKCA (UK Conformity Assessed) mark will be needed in order to place a device on the GB market. Until then, the UKCA mark can be used voluntarily and CE marking will continue to be recognised and accepted.
  • The name and address of the UK Responsible Person must be included on product labelling where the UKCA mark has been affixed. This is not necessary for CE marked devices.
  • UK Notified Bodies have become UK Approved Bodies. A UK Approved Body is needed where third party conformity assessment is required. The government has set up a new database of UK Market Conformity Assessment Bodies.
  • Manufacturers of Class I medical devices and general IVDs can self-declare conformity before affixing a UKCA mark and placing the device on the market [2].
  • Certificates issued by EU-recognised Notified Bodies will continue to be valid for the GB market until 30 June 2023. Third party conformity assessment for CE marking must be carried out by an EU-recognised Notified Body.
  • Where the device already has a valid CE mark, there is no requirement to re-label it with a UKCA mark until 1 July 2023. Dual marking will continue to be accepted after that date.
  • The number of the Notified or Approved Body must appear on the label.

Recent regulatory changes for coronavirus test devices

The Regulations were recently amended [3] 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).

How we can help

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] 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).

[2] Class I medical devices that are sterile or have a measuring function require UK Approved Body approval first.

[3] By The Medical Devices (Coronavirus Test Device Approvals) (Amendment) Regulations 2021.

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