Consultation outcome

Assessment of the requirements under the Medicine and Medical Devices Act 2021

Updated 26 June 2022

The Secretary of State’s overarching objective when making regulations under section 15 of the Medicines and Medical Devices Act 2021 (MMD Act) must be safeguarding public health. The Secretary of State must have regard to the following when considering whether the regulations would contribute to the ‘overarching objective’:

• the safety of medical devices
• the availability of medical devices, and
• the likelihood of the UK being seen as a favourable place in which to carry out research relating to medical devices, develop medical devices, and manufacture or supply medical devices.

Where regulations may have an impact on the safety of medical devices, the Secretary of State may only make the regulations if he considers that the benefits of doing so outweigh the risks.

The MHRA have prioritised these considerations in our proposed changes to the medical device regulatory framework.

The regulatory framework for medical devices intends to improve and safeguard public health, better assuring the safety and quality of devices placed on our market by:

• Regulating medical devices more stringently, ensuring medical devices receive adequate scrutiny before they reach the market and sufficient post-market surveillance and responsiveness to any post-market issues. The Independent Medicines and Medical Devices Safety Review highlighted the need for improved regulation of implantable devices and our future regulatory framework intends to deliver on this.
• Increasing device traceability.
• Introducing a range of more stringent pre- and post-market requirements for medical devices, including for clinical evaluations and performance studies, which intends to drive up patient safety standards.

The regulations aim to improve the safety of medical devices while also meeting fast-moving developments and enabling innovation by:

• Modernising the scope and classification rules of medical devices and in vitro diagnostic medical devices to deliver meaningful improvements in the safety of medical devices and certain other products with a non-medical purpose. This will also align with international best practice, ensuring that the UK is seen as a favourable place to do business.
• Strengthening the accountability of manufacturers, importers and distributors engaged in the supply of medical devices to drive up safety standards.
• Supporting the identification of potential equity issues in medical devices arising from patient characteristics such as ethnicity and sex and improving standards to tackle these disparities, increasing the safety and availability of effective medical devices for all.

The updates to the regulations intend to support the availability of medical devices across the UK, whilst providing the necessary regulatory oversight to ensure that patients receive treatment with devices of the highest quality and safety standards. The MHRA aims to deliver on this ambition through:

• Introducing alternative routes to market to support increased availability of innovative devices and streamlining access to our market while creating a regulatory system that is safe, innovative, patient-centred, and fit for the future.
• Creating a novel pathway to market for software as a medical device, addressing challenges ahead of our international peers to ensure that the UK is favourable place for innovation without compromising on safety.

The regulations aim to modernise our rules to better align with international best practice and keep pace with technological advances. This will ensure that the UK remains a favourable place to do business for the benefit of patients and carers through proportionate regulation, through:

• Introducing new routes to market which aim to promote international trade and collaboration, increasing availability of medical devices to the UK market and supporting the MHRA’s ambition for global harmonisation for medical devices regulation, with patient safety at the heart.
• Supporting a thriving MedTech industry through appropriate transitional arrangements.
• Aligning with international best practice where this is to the benefit of UK patients and diverging only where advantageous to do so, ensuring the most appropriate regulations are in place to prioritise patient safety while reinforcing our reputation as a favourable place to develop and supply medical devices.
• Creating a regulatory framework that is fit for the future for the regulation of software and artificial intelligence as medical devices and leading the way for sustainability, enabling digital and environmental pioneers to actualise lasting value for the health system and society at large.

Throughout this government response, the MHRA aims to have demonstrated how we have listened and responded to themes concerning patient safety, availability of medical devices, and the favourability of the UK as a place to research, develop, manufacture and supply medical devices. The MHRA aims to create a new balanced framework for medical devices regulation that ambitiously yet pragmatically supports the UK’s MedTech industry and delivers on the overarching objective of safeguarding public health.