New MHRA Roadmap

Title: Paving the Way for Enhanced Medical Device Regulations in 2024

Introduction - new MHRA ROADMAP:

In a significant move towards bolstering the regulatory landscape for medical devices, the UK Medicines and Healthcare products Regulatory Agency (MHRA) has unveiled its comprehensive roadmap for 2024. This roadmap not only outlines the agency's strategies for the upcoming year but also sets the stage for crucial discussions on core regulations with stakeholders. The MHRA's proactive approach aims to ensure patient safety, encourage innovation, and establish international harmonization in the evolving field of medical technology.

Key Developments in Future Regulations:

The MHRA's roadmap, released on December 9, provides insights into its plans for implementing future medical device regulations. Among the pivotal changes are the introduction of implant cards for patients to monitor their devices, the incorporation of unique device identifiers (UDIs) for enhanced traceability, and the reclassification of certain devices to align with international standards set by the International Medical Device Regulators Forum (IMDRF). Additionally, the agency seeks to create a framework for recognizing medical devices conforming to comparable regulatory regimes and expedite market entry for products with Medical Device Single Audit Program (MDSAP) certificates.

Enabling Regulation Through Statutory Instruments:

Emphasizing its commitment to patient safety, the MHRA intends to implement priority measures in 2024, with the core elements of the new framework expected to be in place by 2025. The proposed regulations aim to foster international harmonization, with a focus on patient-centered, proportionate requirements responsive to technological advancements in the medical device industry.

SaMD and AI/ML Regulations - new MHRA ROADMAP:

A pivotal aspect of the roadmap is the development of regulations for Software as a Medical Device (SaMD), as well as artificial intelligence and machine learning (AI/ML) products. The MHRA plans to release three SaMD guidances, covering topics such as good machine learning practices, AI as a Medical Device (AIaMD) development and deployment best practices, and data-driven SaMD research. Additionally, the agency is set to launch the AI-Airlock project, a virtual regulatory sandbox facilitating AI developers in generating monitored data for their products.

Reflections on 2023 and CE Mark Acceptance:

Looking back at 2023, the MHRA's roadmap highlights its efforts to allow certain medical devices to remain on the market during the EU's transition to the Medical Device Regulation (MDR) and the In Vitro Diagnostic Medical Device Regulation (IVDR). The agency outlines its plan to extend the acceptance of CE marked medical devices in Great Britain until critical deadlines, acknowledging the delays faced by the EU in transitioning to the new regulatory framework.

Transitional Measures and Future Developments:

The roadmap provides detailed information on transitional measures, allowing certain CE marked medical devices and in vitro diagnostic devices to stay on the GB market until specified dates. Manufacturers are advised on compliance requirements, including the acceptance of self-declared CE marked Class I medical devices and the placement of custom-made devices on the Great Britain market as it is mentioned in the new MHRA ROADMAP.

Forward Momentum: IVD Regulations and Postmarket Surveillance:

Looking ahead, the MHRA outlines its intention to develop a roadmap for In Vitro Diagnostic (IVD) regulations in 2024. As part of ongoing efforts to update regulations, the agency plans to introduce legislation to implement postmarket surveillance (PMS) requirements, as it is mentioned in the new MHRA ROADMAP. These requirements aim to provide clarity on the expectations for manufacturers, emphasizing the importance of post-market surveillance systems and reporting findings to the agency.

Conclusion:

The MHRA's 2024 roadmap signals a proactive and dynamic approach to enhancing medical device regulations in the UK, by new MHRA ROADMAP. By prioritizing patient safety, embracing technological advancements, and fostering international collaboration, the agency is poised to usher in a new era of regulatory excellence in the rapidly evolving field of medical technology. As stakeholders engage in discussions on the proposed regulations, the roadmap lays the foundation for a robust and adaptive regulatory framework that aligns with the evolving needs of the healthcare industry.

MHRA document to download