Recently released ideas to tighten medical device regulation are intended to increase patient safety and promote innovation. The Medicines and Healthcare Products Regulatory Agency (MHRA) now has a rare chance to enhance the regulation of medical equipment and in vitro diagnostic medical devices (IVDs) in the UK with UK’s exit from the EU.
The reforms will cover dermal fillers and other cosmetic products, including x-ray machines, hearing aids, and insulin pumps, in addition to new technology like smartphone apps and artificial intelligence.
The updated policies include-
- Giving the public and patients more assurance about the safety and reliability of the highest-risk medical equipment, such as those that need implanting, would strengthen the MHRA’s ability to take action to keep patients safe.
- Enhancing existing systems to better safeguard users of medical devices and specific cosmetic items will provide greater assurance of their effectiveness and safety. Increasing the scope and depth of regulations to respond to public needs.
- Addressing health inequalities and reducing identified inequities during the development and use of medical technologies—reducing medical device disparities and ensuring that they work as intended for a variety of populations. To address health inequalities, the government has started an assessment into potential equity concerns in the development and application of medical devices. The evaluation will be revised as necessary.
- Considering the UK a hub for innovation and the ideal location to create and market cutting-edge medical products, ensuring that the new regulatory framework promotes ethical innovation to improve patients’ access to the most cutting-edge medical devices in the UK.
- Creating the new UKCA mark and establishing industry-leading standards Making a new certification mark—replacing the CE mark—that people can trust to indicate that medical device items have been produced in compliance with all applicable safety, health, and environmental protection criteria. This will enhance the MHRA’s credibility globally and its expanding collaborations with other regulators.
The laws will be updated to reflect new and developing technology, such as software and artificial intelligence (AI), which are increasingly employed in areas including screening and diagnosis, managing chronic illnesses, and creating new medicines. In order to protect patient safety and promote innovation so that UK patients are one of the first to have access to cutting-edge healthcare, the new regulations will make sure that breakthroughs like these are held to the same high standards as medical devices.
The announcement made today comes in the wake of a consultation on the future regulation of medical devices, during which the MHRA sought opinions on a wide range of regulatory issues, including those relating to the conduct of clinical investigations; the evaluation of devices prior to their release onto the market; importer and distributor commitments; and post-market safety training to build awareness and the role of patients.
The MHRA will make sure that legislative reforms to the system suit the interests of business and the healthcare sector as part of this ambitious, transformative reform initiative. While modifying the law and putting new policies into place, ongoing work will be done and stakeholders and the industry will continue to be engaged.
To allow the industry adequate time to adjust, the MHRA will progressively phase in the new regulations with transitional measures.