MHRA details plans for future medical device, IVD regulations

The UK Medicines and Healthcare products Regulatory Agency has adopted a roadmap that details its plans for 2024, including future core regulations it plans to develop.

On 9 December, MHRA published a document on how it plans to implement future medical device regulations and a roadmap detailing steps it will take over the next year to ensure products stay in Great Britain while also encouraging manufacturers to bring new products. The agency listed 11 future core regulations that it plans to discuss with stakeholders in the first half of 2024.

They include requiring implant cards so that patients can keep track of their devices, requiring unique device identifiers (UDI) so products are easier to track, changing the classification of certain devices such as software as a medical device (SaMD) so they better align with requirements set by the International Medical Device Regulators Forum (IMDRF), and creating a framework for international recognition of medical devices that conform to comparable regulatory regimes and recognizing products that have Medical Device Single Audit Program (MDSAP) certificates so they can enter the GB market sooner.

“The MHRA’s roadmap sets out a route to deliver enabling regulation via a series of new Statutory Instruments (SIs),” said MHRA. “Priority measures to protect patient safety will be put in place this year, with core elements of the new framework intended to be in place by 2025.”

“The planned regulations are also designed to deliver greater international harmonisation, with more patient-centred, proportionate requirements for medical devices which are responsive to technological advances,” the agency added.

An important focus of the roadmap developing regulations for SaMD, and artificial intelligence and machine learning (AI/ML) products. MHRA plans to publish at least three SaMD guidances over the year, including one on good machine learning practice for medical device development mapping, another on AI as a Medical Device (AIaMD) development and deployment best practices, and a guidance on data-driven SaMD research.

The agency also plans to launch its AI-Airlock project this year, which it calls a “regulatory sandbox.” The project is envisioned as a virtual platform where AI developers can generate data for their products that can be monitored by regulators.

The roadmap also looks back at 2023 on the work MHRA has done, including how it will allow certain medical devices to stay on the market while the European Union continues to transition to the Medical Device Regulation (MDR) and the In Vitro Diagnostic Medical Device Regulation (IVDR). The roadmap extends critical deadlines to keep products on the market and details medical device and IVD regulations the agency will consider this year.

MHRA outlined its plan to extend the acceptance of CE marked medical devices in GB, which is in response to a 2021 government consultation to ensure products remain in the country. The EU is in the process of transitioning the regulation of medical devices and IVDs from its Medical Devices Directive (MDD) and In Vitro Diagnostic Directive (IVDD) to the MDR and IVDR but has faced a number of delays, and the agency published a timeline as part of the roadmap.

While the UK is no longer a part of the EU, its medical products continue to use EU CE mark requirements to stay on the market. MHRA noted the UK government has introduced legislation that extends deadlines for CE-marked products to stay on the market while the EU continues to transition to the new regulatory framework.

Medical devices with a valid declaration and CE mark that comply with MDD or the EU Active Implantable Medical Devices Directive can stay on the GB market until 30 June 2028, or until their certificate expires. Similarly, CE marked IVDs compliant with the IVDD can stay on the market until 30 June 2030, or until their certificate expires.

After those dates, medical devices and IVDs that are compliant with MDR and IVDR can remain on the UK market until 30 June 2030.

The legislation also allows self-declared CE marked Class I medical devices to stay on the GB market until 30 June 2030 if they are self-declared against EU MDR. CE marked devices that are self-declared against MDD requirements before 26 May 2021, including upclassified devices and reusable surgical instruments, where notified body (NB) involvement isn’t required in their self-assessment under MDD but is required under MDR can stay on the market until 30 June 2030.

Manufacturers of Class I medical devices that have a sterile or measuring function with a valid MDD certificate can also remain on the market until 30 June 2028.

“Class I medical devices and general IVDs under the Directives, for which the conformity assessment under the EU MDD or EU IVDD did not require a notified body, can only be placed on the Great Britain market if the involvement of a notified body would be required under the EU MDR or IVDR (i.e., if it is an upclassified device or a reusable surgical instrument Class I device),” MHRA added. “Custom-made devices that are compliant with the EU MDD or EU AIMDD can no longer be placed on the Great Britain market.”

“If placing medical devices on the Great Britain market under these transitional measures, manufacturers will not be able to rely on expired certificates (unless such certificates have been otherwise deemed valid by the EU),” the agency added.

MHRA also notes in its roadmap that it plans to develop a roadmap for IVD regulations this year.

As part of its work to update its medical devices and IVD regulations, MHRA also plans to introduce legislation in parliament to implement its postmarket surveillance (PMS) requirements as part of its 2022 consultation response on medical devices in the UK. The requirements are intended to clarify the agency’s expectations for manufacturers to implement post-market surveillance systems and require them to summarize their findings to the agency.

Roadmap announcement

Future regulation implementation plan

MHRA details plans for future medical device, IVD regulations

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