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MHRA releases consultation on regulatory reform for medical devices
In the past several months, the UK Medicines and Healthcare products Regulatory Agency (MHRA) has made significant strides in its efforts to revise the UK medical device regulatory framework. With this reform, the MHRA seeks to achieve three core goals: prioritise patient safety, ensure patients continue to have timely access to the devices they need, enhance the UK’s position as a world-leading environment for medical technology innovators, and implement greater international harmonisation.
While serious discussion about the changes began in 2021, activities have ramped up this year. Since January 2024, the MHRA has released a roadmap for new medical device regulations and laid The Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024 in Parliament. The draft Post-Market Statutory Instrument (SI) still awaits Parliamentary approval.
In the meantime, the MHRA is also seeking input on pre-market measures. A consultation on Medical Devices Regulations: Routes to market and in vitro diagnostic devices was published in November. It is a precursor to a proposed SI that the agency is expected to introduce before Parliament in early 2025.
Key details of the consultation
The MHRA is specifically consulting on four areas related to pre-market regulations:
- International reliance. Currently, medical devices need to have a UK Conformity Assessment (UKCA) marking or an EU conformity assessment (CE) marking to be placed on the Great Britain (GB) market. The consultation proposes that an international reliance scheme could serve as an alternative to the UKCA process. This would enable swifter market access for certain devices that have already been approved as safe and effective in a comparable regulator country.
- UKCA marking. The MHRA is proposing to remove the requirement that the UKCA marking be physically affixed to medical devices that have gone through the UK conformity assessment process. Instead, the MHRA will require manufacturers to assign Unique Device Identifications (UDIs) to medical devices and register them with the MHRA before they are placed on the GB market to improve device traceability.
- In vitro diagnostic devices. The MHRA plans to enhance international harmonisation by amending the in vitrodiagnostic (IVD) device risk classification system to align with the structure used by the International Medical Device Regulators Forum and the EU. The consultation outlines the MHRA’s proposed conformity assessment procedure for IVDs. The majority of devices will be reclassified into a higher risk class. However, the MHRA will allow IVDs classified as Class A or B to self-declare conformity without an assessment by a UK approved body.
- Assimilated EU law. The UK’s current medical device framework, the Medical Devices Regulation 2002, includes several assimilated EU Directives that were transposed into domestic law. Four of those assimilated laws were due to sunset on 26 May 2025. The MHRA is proposing to remove the revocation dates of those laws so that they continue to apply in GB until they are replaced with an updated domestic law.
Looking ahead
Stakeholders have until 5 January 2025 to respond to this consultation. Since the results of this consultation will help build a new medical devices regulatory framework for the UK, companies in the medical device supply chain should take advantage of the opportunity to weigh in. While this consultation is relatively limited in scope, it proposes changes that could have significant impacts for operational efficiency, labelling, marketing authorisations, and international harmonisation.
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