Medical-device AI — FDA PCCP, IEC 62304 and EU MDR plus the AI Act

FDA’s final PCCP guidance (August 2025) recommends that a predetermined change control plan describe the planned device modifications, the associated methodology to develop, validate, and implement those modifications, and an assessment of the impact of those modifications. FDA reviews the PCCP as part of a marketing submission. The January 2025 lifecycle/marketing-submission document is still draft and not for implementation.

IEC 62304:2006 defines the life cycle requirements for medical device software when software is itself a medical device or … an embedded or integral part of the final medical device. It does not cover validation and final release of the medical device.

On the Commission AI Act Service Desk Annex I (consolidated AI Act as at 27 July 2026), Regulation (EU) 2017/745 remains Section A item 11. That listing is the official interplay we cite. It is not a single merged certificate. No listing here names that Annex I MDR interplay as a product tag. ComplianceQuest names FDA Predetermined Change Control Plans (PCCP) and IEC 62304 lifecycle requirements. ENVOLOK checks a modification against an FDA-authorized PCCP. Aligned Elements names pre-defined IEC 62304 Design Control templates. LDRA names a medical-devices sector heading. CycloneDX says it is authorized for use by medical device manufacturers.