Key Takeaways
- A debate on medical technology regulations and the NHS is scheduled for Tuesday, March 28 at 4.30 pm.
- Medical devices are regulated by the MHRA in the UK.
- Medical devices in the UK currently require either a UKCA or CE marking.
- The Medicines and Medical Devices Act (2021) grants the government powers to amend the Medical Devices Regulations 2002.
- A new medical devices legislative regime is set to be introduced from July 2023.
- The MHRA will receive £10 million to expedite the approval process for innovative medicines and medical technologies.
Medical technology regulations and the NHS: The debate
A debate focusing on ‘medical technology regulations and the NHS’ is set to take place in Westminster Hall on Tuesday, March 28 at 4.30 pm. The discussion will be led by Dame Caroline Dinenage MP.
Medical devices
Medical devices encompass a wide range of instruments, from surgical tools to medical apps, that are used for the diagnosis, monitoring, treatment, or management of medical conditions. The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for regulating the UK medical devices market. To be marketed in Great Britain, medical devices must carry either a UKCA or CE marking, signifying compliance with relevant regulations and safety standards.
Regulation
Much of the UK’s medical device regulation derives from EU legislation. The regulatory procedures for medical devices are currently set out in the Medical Devices Regulations 2002, which implemented three EU Directives into domestic legislation. Since January 1, 2021, there have been changes to how medical devices are placed on the market in Great Britain.
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, with plans to introduce a new medical devices legislative regime from July 2023.
The MHRA aims to develop a future regime for medical devices that enables improved patient and public safety, greater transparency of regulatory decision-making and medical device information, close alignment with international best practices, and more flexible, responsive, and proportionate regulation of medical devices.
Government response to consultation
The government published its response to the consultation in June 2022. 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.
The MHRA is set to introduce legislation by Spring 2023 that will bring into force the transitional arrangements and post-market surveillance requirements, which involve identifying any issues with a device and taking action to protect public health if necessary.
MHRA funding and regulatory reforms
During the 2023 Spring Budget, the Chancellor announced that the MHRA would receive £10 million to help expedite the approval process for innovative new medicines and medical technologies. 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, allowing rapid sign-off for medicines and technologies already approved by trusted regulators in other parts of the world. Additionally, a swift new approval process will be set up for cutting-edge medicines and devices to ensure that the UK becomes a global center for their development.
