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MHRA sets out workplan to support safe access to medtech

Posted on the 22nd January 2024

Medtech Regulations

The Medicines and Healthcare products Regulatory Agency (MHRA) in the UK has unveiled a comprehensive two-year workplan for the development of new regulations for medical devices.

The roadmap, outlined through four Statutory Instruments (SIs), is designed to prioritize patient safety, facilitate access to innovative medical technologies, and ensure the UK remains an attractive market for medical technology innovators.

To achieve these goals, the MHRA will enhance post-market surveillance (PMS) requirements, ensuring a robust framework for monitoring device safety.

Additionally, a stakeholder discussion mechanism will be established to encourage collaborative input on core regulations. The roadmap also introduces a dedicated framework for emerging technologies, including implantable devices and healthcare artificial intelligence.

The first significant change, the implementation of PMS requirements, is anticipated to be in place by 2025.

Implementation of the future regulations:

The government's intention to introduce new regulations is outlined in its response to the 2021 consultation on the future regulation of medical devices in the UK.

These emphasize a proportionate, phased approach to implementation, supporting system readiness and minimizing the risk of supply disruption for UK patients.

Transitional arrangements:

To assist with the transition to the future regulatory framework, the government has amended The Medical Device Regulations 2002.

This legislation extends the acceptance of CE-marked medical devices in the Great Britain market.

It also addresses the placement of self-declared CE-marked Class I medical devices on the Great Britain market beyond 30 June 2023, provided certain criteria are met.

Post-market surveillance requirements:

The government plans to introduce legislation in 2024 to enforce strengthened post-market surveillance (PMS) requirements in Great Britain.

This reflects a commitment to improving patient safety as part of future medical device regulations. A draft Post-market Surveillance Requirements Statutory Instrument (PMS SI) was notified to the World Trade Organization (WTO) in July 2023, outlining details on PMS systems, enhanced incident reporting obligations, and more stringent requirements for manufacturers.

The PMS SI is expected to be laid in the first part of 2024 and applied by the end of the same year.

Future core regulations:

Stakeholder discussions on future core regulations are planned for the first half of 2024.

These discussions will provide early insights into detailed policies developed from the consultation response.

The future core regulations aim to introduce several improvements, including enhanced requirements for implantable medical devices, unique device identifiers (UDIs), changes to device classifications and strengthened quality management systems.

The regulations are also designed to bring essential requirements for medical devices in GB into greater alignment with those of the EU and introduce a framework for international recognition that will allow faster access to devices already approved by comparable regulators.

Updates to guidance:

Collaboration with industry, trade associations, and the wider medical devices community is underway to support the effective implementation of new regulations.

The regulatory changes will be accompanied by guidance to assist the medTech sector in interpreting the new requirements.

Related: MHRA introduces new procedures for Marketing Authorisation Applications

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