AI Assurance Directory

Industry

Medical devices

AI-enabled device software, IEC 62304 software lifecycle, and EU MDR listed in AI Act Annex I. Sources last checked 15 October 2026.

Which AI assurance tools actually help you certify — with the cited evidence? For medical devices: 17 listed tools, 3 cited frameworks, 4 source-cited articles, each linking its official source.

Pro path: Medical-device AI: vendor questions · Medical-device AI: GMLP, FDA list and IEC 62304 amendment — full questions and CSV are Pro. See Pro plans.

Cited overview

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 The January 2025 lifecycle document is still draft and not for implementation.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 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 merged certificate. See Medical-device AI.

Frameworks

  • FDA AI-DSF / PCCP

    FDA recommendations for AI-enabled device software functions, including optional predetermined change control plans (PCCPs) reviewed with a marketing submission. Not a certification standard.

    Tools tagged FDA AI-DSF / PCCP

  • IEC 62304

    Life-cycle requirements for medical device software when the software is itself a medical device or is embedded in one. Does not cover validation and final release of the medical device.

    Tools tagged IEC 62304

  • EU MDR + AI Act

    Regulation (EU) 2017/745 remains Union medical-device law. The AI Act Annex I Section A still lists that regulation as item 11, so Article 6(1) high-risk classification can apply when an AI system is a safety component of, or is itself, such a product.

    Tools tagged EU MDR + AI Act

Listed tools

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Buyer kit

Public teaser only. Vendor questions and CSV stay Pro. Medical-device AI: vendor questions — Vendor questions from FDA PCCP guidance, IEC 62304:2006 and AI Act Annex I item 11 (MDR).

Medical-device AI: GMLP, FDA list and IEC 62304 amendment — Vendor questions from FDA’s GMLP page, FDA’s AI-enabled device list and the IEC 62304 consolidated catalog page.

Articles

Questions

Is a PCCP a device certification?

No. FDA reviews a predetermined change control plan as part of a marketing submission. The January 2025 lifecycle document is still draft and not for implementation.

Does listing MDR in AI Act Annex I merge the two certificates?

No official Commission page we cite says that. Annex I Section A item 11 still names Regulation (EU) 2017/745. That is the interplay we record. IEC 62304 remains a software life-cycle standard.

Sources for this overview

These official pages support the overview above. They are not endorsements.

Sources last checked on 15 October 2026.

  1. Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions - FDA
  2. IEC 62304:2006 — Medical device software — Software life cycle processes - IEC
  3. AI Act Service Desk: Annex I - European Commission

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