The future of medical device regulation: government response

What is the background?

The Medicines and Healthcare products Regulatory Agency (the MHRA) has consulted on proposed changes to the UK’s regulatory framework for medical devices in autumn 2021, seeking views on the development of a future legislation that would provide:

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

The views of patients, developers, clinicians and other healthcare professionals were sought to shape the future UK regime. The government recently released its response.

The answer

The answer is long and details the proposed new framework. The changes are expected to apply from 1 July 2023, although this is subject to transitional arrangements and the introduction of secondary legislation. The response includes chapters on the following topics:

  • Scope of the regulations;
  • Classification;
  • Economic operators;
  • Registration and unique identification of the device;
  • Approved bodies;
  • conformity assessments;
  • Clinical investigation and performance studies;
  • Post-market surveillance, vigilance and market surveillance;
  • in vitro diagnostic medical devices;
  • Software being a medical device;
  • Implantable devices;
  • Other Product-Specific Changes;
  • Environmental sustainability and other public health impacts; and
  • Alternative routes to market.

Outside of the scope of the consultation, the MHRA has also announced a work program for the regulation (wider guidance, policies and standards) of health-related software and AI.

What did the government say?

The MHRA received strong support for a number of proposals:

  • Improve patient safety and public health through appropriate regulatory oversight. This includes extending the scope of regulation to certain non-medical devices (including dermal fillers and colored contact lenses) and strengthening and increasing post-marketing surveillance for better follow-up incidents.
  • Improved traceability of medical devices, including the use of unique device identification.
  • Improved regulation of new areas including software and AI as a medical device, to offer alternative and safe routes to the innovation market. There was also strong support for introducing pre-approval pathways for innovative devices.
  • Support for the Equity in Medical Devices Review, recognize the role that the MHRA will play in setting regulatory standards for fair outcomes, ensuring that medical device manufacturers can demonstrate the safety of their products to diverse populations.
  • Introduce alternative marketing routes while ensuring that the UK aligns with international best practice where these standards are higher in the UK.

The way forward for UK medical device regulation

While the consultation looked at a number of options for how the new requirements for medical devices could be phased in, the government response proposes different transition processes for devices marked UK Conformity Assessed (UKCA), devices CE, i.e. those that currently comply with the EU regulatory framework, and clinical investigations.

UKCA-marked medical devices may be marketed until the certificate expires or for three years after the regulations come into force (or five years for in vitro diagnostics). The transitional arrangement ends if the certificate expires before the three or five year window.

The intention of the transitional arrangements is to ease the transition and support the continuity of supply of medical devices in the UK. When the transitional window expires, all clinical products and investigations will need to comply with UK medical device regulations.

What to do next

Increased regulation is intended to result in improved patient safety and public health, which can only be positive. However, companies operating in the sector (regardless of their role in the supply chain) will need to pay close attention to what is expected of them under the new legislation to ensure continued compliance and avoid disruption of supply. activity in the coming months. Understanding and taking advantage of all available transitional provisions will be essential for businesses to maximize the time available to comply with new regulations.

It is important to note that for companies supplying medical devices to the UK as well as the EU, diverging regulatory frameworks will require effective planning to achieve compliance in both markets in a timely manner. In addition, the implementation of a robust compliance program to ensure continued compliance and the ability to effectively meet obligations in both markets in the future will be essential.

About Marion Alexander

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