Consultation on revising UK medical devices regulations initiated

MHRA launch consultation process to update UK regulatory requirements

The EU Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR) were not transposed into law in Great Britain.  The Medical Devices Regulations 2002 (SI 2002 No 618, as amended), which implemented the Directives for active implantable medical devices, medical devices and in vitro diagnostic medical devices (IVDs) in the UK, continue to have effect in Great Britain.

The Medicines and Medical Devices Act 2021 provided the authority to amend the regulations for medical devices, with the stated overarching objective of safeguarding public health. Under that overall objective, the Act indicates that any new regulations should consider the following factors:

• the safety of medical devices
• the availability of medical devices
• the likelihood of the UK being seen as a favourable place in which to carry out research relating to medical devices, develop medical devices, and manufacture or supply medical devices.

The Medicines and Healthcare products Regulatory Agency (MHRA) are looking at ways to update the UK regulations on placing medical devices on the UK market. The MHRA have launched a consultation exercise to get input on potential changes to the regulatory regime from patients, medical device researchers, developers, manufacturers and suppliers, clinicians, other healthcare professionals and the wider public. The consultation was published on 16 September 2021 and runs for 10 weeks.

The consultation seeks input on questions related to:

• the scope of the regulations
• classification of devices
• responsibilities of manufacturers, importers and distributors
• registration and unique device identification (UDI)
• approved bodies
• conformity assessment processes
• clinical investigations and performance studies
• post-market surveillance, vigilance and market surveillance
• in vitro diagnostic devices
• software as a medical device
• implantable devices
• re-manufacture of single use devices
• kits, systems and procedure packs
• parts and components
• custom-made devices
• environmental sustainability and public health impacts
• routes to market, and
• transitional arrangements.

The MHRA have indicated that they plan to introduce the new regulatory regime at the beginning of July 2023. This aligns with the date from which the UK is due to stop accepting CE marking for medical devices in Great Britain and will require the use of the UKCA mark.

It is important to be aware of the distinction between Great Britain – England, Scotland and Wales – and the United Kingdom, which comprises Great Britain and Northern Ireland. Northern Ireland follows certain EU rules, with the Medical Devices Regulation (2017/745) (EU MDR) having taken effect from 26 May 2021. The EU in vitro Diagnostic Medical Devices Regulation (2017/746) (EU IVDR) will apply in Northern Ireland from 26 May 2022. This consultation exercise sets out proposals for a future UK-wide regime to regulate medical devices. In Northern Ireland, such a regime should run in parallel with any existing or future EU rules in accordance with the Northern Ireland Protocol.

Anyone with an interest in the regulation of medical devices in general and the UK market in particular should take the opportunity to review the consultation documents and provide their input into the consultation process. The consultation closes on 25 November 2021.

Author: Eamonn Hoxey, of E V Hoxey Ltd, UK, is a writer, trainer and consultant on a range of life science areas including regulatory compliance, quality management, sterility assurance and standards development