Medical technology regulations and the NHS

Medical technology regulations and the NHS

A debate on ‘medical technology regulations and the NHS’ has been scheduled in Westminster Hall on Tuesday 28 March at 4.30pm. The debate will be opened by Dame Caroline Dinenage MP.

Medical devices

A medical device is any instrument (other than a medicine) that is used to diagnose, monitor, treat or manage a medical condition. The definition covers a wide range of products including syringes, dressings, surgical tools, scanners, software, apparatus, machines and some medical apps.

The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for regulating the UK medical devices market.

A medical device cannot be put on the market in Great Britain unless it has a UKCA or a CE marking. A CE marking shows that the medical device complies with the relevant EU medical device regulations and that the manufacturer has checked that the product meets “EU safety, health or environmental requirements”. A UKCA marking (the UK equivalent of the CE mark) shows the medical device meets the requirements of the UK medical devices regulations and, when used as intended, works properly and is acceptably safe.

Regulation

Much of the regulation of medical devices in the UK derives from EU legislation. The regulatory procedures for medical devices are currently set out in the Medical Devices Regulations 2002 (as amended) which implemented into domestic legislation three EU Directives:

• Medical Devices Directive (93/42/EEC) (as amended by 2007/47/EC)
• Active Implantable Medical Devices Directive (90/385/EEC); and
• In Vitro Diagnostic Medical Devices Directive (98/79/EC).

Since the 1 January 2021 (the end of the transition period), there have been changes to the way medical devices are placed on the market in Great Britain. Further information is provided by the MHRA at:

Regulating medical devices in the UK - GOV.UK (January 2022).

Future regulation of medical devices

The Medicines and Medical Devices Act (2021) provided the Government with powers to amend the Medical Devices Regulations 2002. In September 2021, the MHRA launched a consultation on the future regulation of medical devices in the United Kingdom. It explained that it planned to introduce a new medical devices legislative regime from July 2023; the date at which the MHRA was due to stop accepting CE marked medical devices in Great Britain and would instead require the use of the UKCA marking. The MHRA also stated that it was aiming to “develop a future regime for medical devices which enabled”:

• Improved patient and public safety;
• Greater transparency of regulatory decision making and medical device information;
• Close alignment with international best practice, and;
• More flexible, responsive and proportionate regulation of medical devices.

Notably, the MHRA referenced the report of the Independent Medicines and Medical Devices Safety Review, led by Baroness Cumberlege, in its consultation document which, it stated, reinforced the need to maintain a focus on patient safety and the safety of medical devices.

The Government published its response to the consultation in June 2022:

• Government response to consultation on the future regulation of medical devices in the United Kingdom (opens PDF)

One of the consultation outcomes is the introduction of ‘transitional arrangements’ to allow a phased introduction of new regulatory requirements for medical devices. This includes an extension to the recognition of CE marked medical devices placed on the market in Great Britain. According to the MHRA, the government “intends to introduce legislation by Spring 2023 that will bring into force the transitional arrangements and post-market surveillance requirements”. The latter involves identifying any issues/problems with a device and, if required, taking action to protect public health.

More recently, during the 2023 Spring Budget, the Chancellor announced that the MHRA would “receive £10 million to help bring innovative new medicines and medical technologies to UK patients more quickly”. The Chancellor also outlined proposed reforms to the regulation of medicines and medical technologies:

From 2024, [the MHRA] will move to a different [regulatory] model, which will allow rapid, often near-automatic sign-off for medicines and technologies already approved by trusted regulators in other parts of the world such as the United States, Europe and Japan. At the same time, it will set up a swift new approval process for the most cutting-edge medicines and devices to ensure that the UK becomes a global centre for their development. With an extra £10 million of funding over the next two years, they will put in place the quickest, simplest regulatory approval in the world for companies seeking rapid market access (HC Deb, 15 March 2023, c841)

Further reading

• Impact of extension of Medical Device Regulations transitional period and the validity of certificates in the EU - GOV.UK, 20 February 2023
• Medical technology strategy - GOV.UK, February 2023
• Medicines and Medical Devices Bill 2019-21 - House of Commons Library (January 2021)
• The Independent Medicines and Medical Devices Safety Review - House of Commons Library (February 2022)
• The Independent Medicines and Medical Devices safety Review (immdsreview.org.uk)
• MHRA to receive £10m from HM Treasury to fast-track patient access to cutting-edge medical products - GOV.UK (www.gov.uk)
• Equity in medical devices: independent review call for evidence - GOV.UK (www.gov.uk)