Module 17 2024

05/12/2024

Chapter 14: Alternative Routes to Market

• In May 2024, the MHRA issued a statement of policy intent that included specific requirements for Artificial Intelligence as a Medical Device (AIaMD), a subset of software as a medical device. • However, the government does not intend to define AIaMD or introduce any AIaMD-specific requirements in legislation at this time. Therefore, the proposed framework does not include specific requirements for these devices. • The MHRA continues to review the list of comparable regulator countries and is in active discussions with the Pharmaceuticals and Medical Devices Agency to explore the reliance on medical device approvals from Japan.

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Chapter 14: Alternative Routes to Market

The following would be excluded from international recognition: • Software as a medical device that has gained access to the USA market via the FDA 510(k) clearance process • Devices that comply with 510(k) legislation in the USA that are classified in GB as Class IIb implantable (excluding the devices listed in Route 4) and Class III • Devices granted market access in CRC via reliance routes • Devices that contain non-viable cells and tissues of human origin

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