Introduction
The UK has typically been an attractive place to launch medical devices. However, following UK’s departure from the European Union, this market position has been less certain. The government body responsible for regulating medical devices, the Medicines & Healthcare products Regulation Agency (MHRA), has laid out a suite of legislative and regulatory changes which are hoped will maintain the UK's momentum as a strong market competitor in the medical devices industry, in particular by embracing rapid advances in medical technologies.
Regulatory changes
MHRA Future Regulations Regime
- The MHRA intends to introduce future regulations to overhaul the current regulatory framework for medical devices in the UK. The "core aspects" of the future regime are set to apply from 1 July 2025.The approach to the MHRA’s reform was outlined in a 2021 consultation. The aim is for a proportionate, phased implementation of the regulations governing medical devices to support system readiness, minimise the risk of supply disruption and prevent dangers to patient safety. The government proposals can be found here.
- However, in advance of the implementation of the new regulatory framework, the government has put in place arrangements to enable a smooth transition away from the EU governed regime.
Transitional arrangements for CE Markings
- The introduction of the Medical Devices (Amendment) (Great Britain) Regulations 2023 (MDAR 2023) which comes into force on 30 June 2023 will extend the period of acceptance of ‘CE’ marked European products in Great Britain, which the government intends to phase out with the equivalent ‘UKCA’ mark. This extension is set to last for one further year, to 30 June 2024. See the government press release here.
- The MDAR 2023 sets out new transitional periods in which valid CE marked medical devices will continue to be accepted for sale in the UK according to the type of device, as follows:
- 30 June 2028: end of transition period for general medical devices compliant with the old EU medical devices directive or EU active implantable medical devices.
- 30 June 2030: end of transition period for in vitro diagnostic (IVDs) medical devices complaint with the EU IVD medical devices directive.
- 30 June 2030: end of transition period for general medical devices compliant with the EU medical devices regulation.
What is useful for companies to know is that the above transitional periods allow manufacturers of medical devices to continue to rely on expired EU MDD certificates to place medical devices on the Great Britain market where they have been deemed valid under the EU Medical Devices Regulations 2002.
The government also intends to introduce legislation later in 2023 that will clarify and strengthen the requirement for manufacturers of medical devices to implement a post-market surveillance system, in respect of all medical devices manufacturers place on the UK market. These post-market surveillance requirements are expected to apply from mid-2024.
Innovative Devices Access Pathway (IDAP)
- With the expanding repertoire of innovative medical technologies changing the provision of healthcare, the government is planning to launch a regulated support service to improve access to patients. The aim of the programme is to bring the NHS an integrated support system which encourages the expansion of innovative technologies.
- IDAP is set for launch in late 2023. It will be run by the MHRA and a range of other bodies including devolved nations partners.
- Innovators of medical technologies are being asked to register their information with IDAP. More details can be found here.
Software and AI as a medical device
- In April 2023, the MHRA published guidance specifically for the use of Software and Artificial Intelligence (AI) as a medical device. See our recent blog post for more information.
Understanding the regulatory landscape
- As a consequence of “Brexit”, it is no surprise that there is significant change occurring to the regulatory landscape governing healthcare. In a bid to help navigate this, UK regulators have launched a website to help developers and adopters of AI and digital technologies in health and social care understand their regulatory obligations. See our blog post for more information.
How can we help?
If you would like to discuss how the current regulatory regime or future changes might impact you or your products, please contact Katie Carter, Patrick Parkin or Rory Trust.
This article was written by Katie Carter and Sasha Anisman.