The Medicines and Healthcare products Regulatory Agency (MHRA) has launched a public consultation on the future of medical device regulation in the UK.
The consultation comes approximately a month after the UK’s Regulatory Horizons Council recommended in its Report on Medical Devices that “Regulatory reform in medical devices is urgently needed”. As the Secretary of State for Health and Social Care (SoS) has remarked, this consultation comes at a fitting moment. It follows the Independent Medicines and Medical Devices Safety Review Report authored by Baroness Cumberlege, which emphasised that the “MHRA needs substantial revision particularly in relation to […] medical device regulation”.
The SoS has considered the need to enhance safety of medical devices used in the UK and that the UK’s departure from the EU has provided the opportunity to reshape the regulatory framework tailored specifically to the Great Britain industry, market and patients.
Those involved in research and development of medical technologies intended for international markets may be concerned with whether the outcome of this consultation will lead to significant divergence of the UK domestic rules from the EU rules and international standards, and whether the proposed rules will affect the future of the UK-based industry in an increasingly competitive market.
As detailed here, the consultation sets out an ambitious menu of 14 principal themes with a view to developing a future regulatory regime for medical technologies that will achieve four key legislative objectives, namely:
Improved patient and public safety;
- Greater transparency of regulatory decision-making and medical device information;
- Close alignment with international best practice; and
- More flexible, responsive and proportionate regulation of medical devices.
These overarching themes have also been addressed in the new EU regulatory framework for medical devices and in vitro diagnostic medical devices for the purpose of creating a robust, transparent and sustainable regulatory framework that improves safety of and fair market access to medical devices.
The overall effect of the proposals seeks to strike a balance between enhancing safety measures whilst incentivising innovation through earlier market access of an innovative medical device. The proposal is consistent with Government’s policy to make the UK a more attractive market for international investment.
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The Consultation was launched on 16 September 2021 and will close on 25 November 2021.