The start of 2024 brought updates and progress in both the EU
and the UK on medical devices regulation. In January, the European
Commission issued proposals to address implementation challenges
faced by medical devices manufacturers, while a Medicines and Healthcare products Regulatory
Agency (MHRA) roadmap outlined UK reforms to deliver greater
cooperation with overseas regulators and likely recognition of
medical devices that are compliant with EU rules.
The EU Medical Device Regulation
In 2016, the European Union (EU) implemented the EU Medical Device Regulation (MDR) (2017/745)
to replace existing directives with the goal of improving safety,
transparency and traceability of medical devices within the
EU.
The EU MDR was published in May 2017 but did not come into force
until 26 May 2021 (after its implementation was delayed due to the
Covid-19 pandemic).
Reform package
The EU MDR reforms included a wider definition of “medical
device”. Some products that had not been regulated as medical
devices were brought within the new framework, such as cosmetic
contact lenses. Conformity assessment procedures and the risk-based
classification system for medical devices were also enhanced, with
increased obligations for high-risk devices. Notified bodies
responsible for initial conformity assessment of high-risk devices
were handed new responsibilities, including to carry out
unannounced audits and post-market surveillance.
New requirements were introduced for conducting clinical
evaluations and investigations to demonstrate compliance with
safety standards and specifications, while manufacturers and
operators were given increased responsibilities for post-market
surveillance and quality management.
Unique device identification numbers and an enhanced European
Database on Medical Devices (EUDAMED) were brought in to facilitate
traceability and transparency of devices and related information.
The new regulations also aimed to establish closer coordination
through information exchanges and coordinated assessments to ensure
implementation and international regulatory cooperation.
EU delays and challenges
While progress has been made in implementing the EU MDR, there
have been a host of significant delays in transitioning medical
devices to the new rules. These delays and challenges are due to
factors such as a shortage of notified bodies and lack of capacity
for device certification, supply chain issues leading to shortages
of raw materials in the EU, and manufacturers not being prepared to
comply with the new regulations.
In order to prevent further disruptions to the supply and
availability of medical devices in the EU and enhance safety and
transparency, the Commission has proposed giving more time to
manufacturers to comply with the EU MDR.
New timeframe proposals
The new proposals include the extension of the transition
periods for manufacturers to comply with the new rules –
high-risk devices would have until December 2027, medium-risk
devices would have until December 2028, and lower-risk devices
until December 2029.
A phased roll-out of the implementation of EUDAMED is also
proposed to facilitate effective implementation of the EU MDR.
Mandatory prior notice for supply interruptions at least six
months in advance would also be required from manufacturers.
Competent authorities, distributors and healthcare providers would
need to be notified if they anticipate a disruption or
discontinuation in the supply of medical devices.
The reaction to the proposals have been positive. MedTech Europe
has emphasised the importance of extended transition periods and
the mandatory use of EUDAMED.
UK medical devices regulatory framework
The UK was a member of the EU when the EU MDR was drafted and
had actively participated in the shaping of the regulations before
Brexit. However, the delayed implementation of the EU MDR meant
that it did not form part of the UK’s “retained EU
law” at the end of the Brexit transition period, which
concluded on 31 December 2020.
The MHRA launched a consultation in 2021 on future UK medical
device regulations. In January 2024, it released the roadmap, which outlined future reform, to
provide clarity and preparation opportunities for medical device
providers and the industry as a whole. The MHRA aims to learn from
the challenges faced during the implementation of the EU MDR regime
in the EU.
The EU MDR and UK timeline: 1993-2030
The roadmap outlines the key action points taken between 2021
and 2023, as well as numerous stakeholder discussions that will
take place throughout 2024, with plans for priority measures to be
in place this year and future core regulations to be introduced
during 2025.
The MHRA intends to establish UK regulations that promote
international harmonisation and prioritise patient-centred and
proportionate rules, including processes to recognise devices
approved by overseas regulators and measures to bring requirements
in line with EU rules.
In the meantime, the latest government extension allowing
manufacturers to place CE- marked medical devices on the market in
Great Britain means that a product compliant with the EU MDR can be
placed on the Great Britain market up until June 2030.
Osborne Clarke comment
Industry will be looking forward to receiving more information
on proposed new UK medical devices regulations as the MHRA begins
to progress with its roadmap. Draft regulations have not yet been
published; however, it appears that the MHRA is considering an
approach for UK regulations that would broadly mirror the EU
model.
Taking into account the MHRA’s statements to date, as well
as the latest extensions allowing CE-marked products onto the
market in Great Britain, medical device manufacturers may find that
compliance with the EU model is an approach that will facilitate
compliance with future medical devices regulations in the UK.
Manufacturers should monitor both available extensions for
compliance with the MDR in the EU, as well as developments in the
UK, as the MHRA adds detail to its proposals.
Jamie Roberts, a Trainee Solicitor with Osborne Clarke,
contributed to this article.
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