How Will the UK’s New Draft Medical Devices Regulations Impact the Healthcare Industry?

Highlights

• MHRA has launched a consultation on new regulations for medical devices and in vitro diagnostics
• Baroness Gillian Merron emphasises these proposals as part of broader medical device regulatory reforms

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has initiated a new consultation on upcoming regulations concerning market pathways for medical devices and in vitro diagnostic devices.

Baroness Gillian Merron, the Parliamentary Under Secretary for Patient Safety, describes the proposals as “a small yet significant element of broader reforms to the regulatory framework for medical devices.” She adds that these measures are part of the government’s commitment to eliminating health inequalities, revitalizing the NHS, and driving growth nationwide.

Four areas are being consulted on by the MHRA:

1. UKCA Marking for Medical Devices: Medical devices or their sterile packaging currently require a UKCA (UK Conformity Assessed) marking to be sold in the Great Britain (GB) However, the MHRA is implementing new measures to enhance device traceability by introducing Unique Device Identification (UDI). This change aims to reduce reliance on the UKCA marking.
2. International Reliance: International Reliance is a framework that enables certain medical devices to enter the GB market more rapidly by leveraging prior approvals from equivalent regulatory authorities in other
3. In vitro diagnostic [IVDs] devices: In vitro diagnostic (IVD) devices will be categorized into four risk classes, determined by the potential risk they pose to patients and public health. Each class comes with specific regulatory requirements for market access, tailored to its risk The MHRA is currently seeking feedback on the regulatory framework for Class B IVDs, which includes lower-risk self-testing devices like pregnancy tests, fertility tests, and cholesterol tests.
4. Assimilated EU Law Update: The revocation dates for four key pieces of European Union-originating legislation have been removed to ensure their continued application until the transition to an updated medical devices These laws include:
   • Commission Decision 2002/364/EC: Establishing common specifications for in vitro diagnostic medical
   • Commission Regulation [EU] No 207/2012: Concerning the provision of electronic instructions for use of medical devices.
   • Regulation [EU] No 722/2012: Setting particular requirements for medical devices manufactured using tissues of animal origin.
   • Regulation [EU] No 920/2013: Governing the designation and supervision of notified

These regulations will remain in effect to ensure continuity and compliance within the medical devices sector.

In the future, the government plans to consult further on additional legislative measures, including the expansion of digital labeling and a modernized approach to health institution exemptions, aligned with the evolving NHS, where care is increasingly community-based.