The UK’s regulatory regime for medical devices is in a state of flux. Great Britain has not implemented the new medical device regulations which are now fully applicable across the EU. Instead, the MHRA is developing plans for a new, world-leading regulatory regime for medical devices in the UK. The MHRA recently published its Delivery Plan 2021-2023, setting out the first hints of what this new regime will look like.
Here are our top 4 takeaways from the Delivery Plan 2021-2023 for medical device manufacturers:
- New legislation is on the way: The MHRA will design, consult on and implement a new legislative framework for medical devices. Following Brexit, the MHRA intends to take advantage of the opportunity to evolve the UK’s regulatory regime through the passing of the Medicines and Medical Devices Act (2021).
- The timelines - 2022 and 2023 are key: The MHRA intends to publish a public consultation covering all key aspects of a proposed market access framework by the end of Q2, 2021/22; lay relevant statutory instruments by the end of Q1, 2022/23; and publish key guidance documents by the end of Q3, 2022/23. The MHRA further intends to publish a consultation on ensuring an integrated UK regulatory pathway for products that combine medicinal products and medical devices by Q3, 2022/23.
- Multi-agency approach: In its design and implementation of the new regime, the MHRA is working with its partners across the healthcare system, including clinicians, NHSX, the National Institute for Health and Care Excellence (NICE), the Health Research Authority (HRA), and NHS Digital.
- Safety surveillance and risk management: A key area of focus for the MHRA is delivering a more responsive safety surveillance and risk management system for all medical products. The MHRA intends to deliver a more responsive system that detects and responds to signals more quickly and enables greater interaction with reporters. The MHRA also intends to work closely with NHS colleagues to support the development of the Medical Devices Information System. The first step for the MHRA will be completing a review on new medical devices signals and risk management processes, embedding a risk assessment template and identifying opportunities for patient involvement by the end of Q1, 2021/22.
Today’s world calls for a new Medicines and Healthcare products Regulatory Agency driving forward a new era in enabling regulation, regulatory science and best evidence.