Proposed updates to the regulation of medical devices

General 3 min
May 10, 2023
Sophie Vo
Sophie Vo
Authors

While it might be challenging for manufacturers of medical devices to navigate the evolving regulations of medical devices in Great Britain following Brexit, the MHRA recently published updates, which offer some clarity in terms of timing. However, it is all still subject to parliamentary approval.

CE marks

In October 2022, the MHRA published an update, stating that the government intends to introduce legislation that extends the acceptance of medical devices with valid CE marks on the Great Britain market beyond 30 June 2023, such that manufacturers will be able to continue to place CE marked medical devices on the Great Britain market after 1 July 2023, with transitional arrangements in place from July 2024.

In a further update at the end of April 2023, the MHRA provided clearer timelines regarding the acceptance of CE marked medical devices for placement on the Great Britain market, which differ depending on the type of medical device and its compliance with the various EU directives. After the period in which the CE mark is accepted, UKCA marks will need to be used for placement on the Great Britain market (by meeting the requirements in the UK Medical Devices Regulations 2002).

In summary:

Type of medical device (and EU legislation under which it was conformity assessed)

When the CE mark is to be accepted until (subject to Parliamentary approval)

General medical devices compliant with the EU medical devices directive or EU active implantable medical devices directive 30 June 2028 (unless certificate expires beforehand)
In vitro diagnostic medical devices compliant with the EU in vitro diagnostic medical devices directive 30 June 2030 (unless certificate expires beforehand)
General medical devices including custom-made devices, compliant with the EU medical devices regulation (EU MDR) and IVDs compliant with the EU in vitro diagnostic medical devices regulation 30 June 2030 (unless certificate expires beforehand)

See the MHRA’s recently updated guidance on regulating medical devices in the UK for more information about getting medical devices certified, conformity marking and registration with the MHRA.

Post-market surveillance legislation

The MHRA also previously indicated the government’s plans to introduce legislation regarding post-market surveillance requirements in response to the consultation outcome for Post-market Surveillance, Vigilance, Market Surveillance, now expected to be introduced later in 2023 (rather than Spring 2023).

We will continue to watch this space for the long-awaited statutory instruments implementing the above changes.

The government intends to put in place legislation in Spring 2023 to extend the acceptance of CE marked medical devices on the Great Britain market. This will support the ongoing safe supply of medical devices to Great Britain and ease the transition to the future regulatory framework for medical devices.

 www.gov.uk/…

Written by
Sophie Vo
Sophie Vo
I am an Associate in the Intellectual Property Group in London with a particular focus on the life sciences and healthcare sectors. I have experience in a broad range of both contentious and non-contentious matters for pharmaceutical, medical device and healthcare clients.

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