Executive Summary
Updated 26 June 2022
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Following our exit from the European Union (EU), we have a unique opportunity to improve how medical devices and in vitro diagnostic medical devices (IVDs) are regulated in the United Kingdom (UK). Powers in the Medicines and Medical Devices Act (2021) allow us to amend the Medical Devices Regulations 2002 which govern medical devices in Great Britain.
The Medicines and Healthcare products Regulatory Agency’s (MHRA) purpose is clear: to protect patients and the public and facilitate access for UK patients to the latest advances the MedTech sector can offer. A strong regulatory foundation, MHRA’s global reputation, strong international partnerships and globally recognised successes during the pandemic all provide a strong platform to build on. This regulatory framework will serve as the cornerstone to realising these opportunities.
Having analysed the many engaged responses to our consultation, our world-leading medical device regulatory framework will be built on five pillars:
- Strengthening MHRA power to act to keep patients safe
- Making the UK a focus for innovation, the best place to develop and introduce innovative medical devices
- Addressing health inequalities and mitigating biases throughout medical device product lifecycles
- Proportionate regulation which supports businesses through access routes that build on synergies with both EU and wider global standards
- Setting world leading standards – Building the UKCA mark as a global exemplar
A considered implementation plan for such an ambitious programme of reform is critical to its success. Our plan balances prioritisation and pace with the need to ensure there is time for the sector to adapt. It seeks to ensure patients and the healthcare system can continue to access the essential medical devices they need through the transition to the UK Conformity Assessed (UKCA) marking.
The Med Tech sector is fast-paced, and our regulatory framework needs to be agile enough to respond. This response sets out measures we consulted on which we will now move to implementation, as well as some where we will need to consult further. Along with our key partners, we will continue to work to develop our approach, keeping patient safety at the heart of the framework and building on the standing of the Medicines and Healthcare products Regulatory Agency as a leading global regulator.