The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has published a new roadmap setting out its timeline for an overhaul of the UK medical device regulations. The MHRA is taking a phased approach, with new legislation pencilled in for 2024 on Post Market Surveillance (PMS) and in 2025 for a wider core framework. Current plans indicate certain areas of alignment with the requirements of the EU Medical Devices Regulation (EU MDR). The MHRA further plans to develop a roadmap for in vitro diagnostics (IVDs) regulations this year.
- Plans for future UK medical device regulations in 2025: The new regulations will be spread out through four statutory instruments. The MHRA will be running consultations regarding this new framework in the first half of 2024, and this framework will reflect elements of the EU MDR and EU IVDR, including:
- introduction of a unique device identifier (UDI).
- changes to the classification of several types of devices, including up-classing certain software as a medical device.
- strengthening the requirements for quality management systems and technical documentation.
- clarifying the requirements for manufacturers, importers and distributors, and introducing a requirement to have a Person Qualified in Regulatory Compliance.
- New legislation in 2024 to strengthen PMS requirements: The government intends to introduce a PMS statutory instrument in the first part of 2024, and this is expected to apply towards the end of 2024. This includes requirements for manufacturers, such as:
- what must be included as part of a PMS system (including methods for collecting PMS data).
- enhanced serious incident reporting obligations.
- more stringent requirements to conduct periodic reviews of PMS data.
- Focus on Software as a Medical Device (SaMD) and AI as a Medical Device (AIaMD): An important focus of the roadmap is SaMD and AIaMD. The MHRA intends to publish at least three pieces of SaMD guidance over the course of 2024, including:
- good machine learning practice for medical device development mapping.
- AIaMD development and deployment best practice.
- data-driven SaMD research, development and governance.
- What’s the status now? Currently, the acceptance of CE marked medical devices in Great Britain remains unchanged. The Medical Device Regulations 2002 (SI 2002 No 618, as amended) (UK MDR) has extended the acceptance of CE marked medical devices in Great Britain as follows:
- general medical devices compliant with the EU MDR and IVDs compliant with the EU IVDR can be placed on the Great Britain market until 30 June 2030.
- general medical devices compliant with the EU Medical Devices Directive (EU MDD) or EU Active Implantable Medical Devices Directive (EU AIMDD) with a valid declaration and CE marking can be placed on the Great Britain market until the earlier of expiry of the relevant certificate or 30 June 2028.
- IVDs compliant with the EU In Vitro Diagnostic Medical Devices Directive (EU IVDD) can be placed on the Great Britain market up until the earlier of expiry of the relevant certificate or 30 June 2030.
There are additional transitional arrangements for certain Class I medical devices.