The UK government intends to introduce new regulations for medical devices. These new regulations will prioritise patient safety, give patients access to the medical devices they need and ensure the UK remains an attractive market for medical technology innovators.The regulations will be delivered through four Statutory Instruments. It is intended that priority measures to enhance post-market surveillance will be put in place first in 2024, with core elements of the new framework expected to be in place in 2025.

The Medicines & Healthcare products Regulatory Agency (MHRA) have published a roadmap for the Software and AI as a Medical Device Change Programme.

The MHRA have an interesting webinar on the topic which is available on YouTube

European Legislation

Europe has transitioned to European Medical Device Regulation, also known as MDR (EU 2017/745). The MDR has introduced an additional classification rule which specifically relates to software. In many cases Class I medical device software will be upgraded to Class IIa or above.

This will require a different conformity assessment route.  The assessment route for devices with a classification higher than class I chosen by most manufacturers is the full quality assurance system (Annex II). The notified body reviews the technical documentation according to the regulatory requirements in the directives and the quality management system (ISO 13485). After a successful audit, the notified body issues two certificates - the QMS certificate and the CE certificate. Annual surveillance audits are conducted thereafter by the notified body.

Future UK Legislation

Although not published, it is anticipated that future UK legislation will mirror the MDR with respect to the introduction of a new classification rule for software.

Regulation of Higher Classification Devices.

It is important to understand that the level of documentation with respect to implementation of a Quality Management System and preparation of Technical File to provide evidence of conformity with the regulation/directive should be very similar for Class I and Class IIa devices. The key difference is that for Class I the manufacturer declares conformity while for higher classifications an external party will confirm conformity.

InnoScot Health implements and is accredited annually to ISO13485:2016 by BSi. As the legal manufacturer, should the software be reclassified the technical file could be assessed during annual surveillance audits.

Although not currently defined, it is anticipated there will be an appropriate transition windows for manufacturers who find themselves in the position of requiring external assessment.

New statutory definition of software as a medical device

The new regulations will set out a statutory definition of software as a medical device (SaMD). The definition Is proposed to be “A set of instructions that processes input data and creates output data”. This new definition will:

• ensure medical device regulations capture the breadth of software to protect patients and the public, and
• ensure there is sufficient clarity yet flexibility of qualification to effectively and proportionality regulate software as a medical device.