Published document record
Medical-device AI: joint AIB/MDCG guidance
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Download PDF — 27 pages (0.45 MB)AIB 2025-1; MDCG 2025-6. June 2025 endorsed guidance.
Source: European Commission, Directorate-General for Health and Food Safety. Retrieved 2026-09-10.
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SHA-256:
48db859581fb5f1677068cd4eca770e062c5fcc2a8483d6459daceeb98478626
Official metadata
- Official title
- Interplay between the Medical Devices Regulation (MDR) & In vitro Diagnostic Medical Devices Regulation (IVDR) and the Artificial Intelligence Act (AIA)
- Official reference
- AIB 2025-1; MDCG 2025-6
- Document type
- Guidelines
- Document date
- 2025-06-19
- Document date kind
- Publication
- Document-date evidence
- European Commission, Directorate-General for Health and Food Safety · Publication date and linked mdcg_2025-6_en.pdf: 19 June 2025. — Publication fallback; the PDF supplies no exact independent issue day.
- Publication date
- 2025-06-19
- Publication-date evidence
- European Commission, Directorate-General for Health and Food Safety · Publication date; matching English download dated 19 June 2025. — Official release of this exact joint guidance.
- Additional official dates
- Cover issue: 2025-06 (month) · European Commission, Directorate-General for Health and Food Safety · PDF p.1: June 2025.
- Version label
- June 2025 endorsed guidance
- Legal status
- Non binding
- Legal-status evidence
- European Commission, Directorate-General for Health and Food Safety · PDF p.1, disclaimer. — Expressly non-binding; endorsed by AIB and MDCG, not a Commission document.
- Language
- en
Research classifications
These are researcher classifications used to organise and analyse the corpus; they are not official EU metadata.
- Record level
- Principal
- Version status
- Final
- Temporal collection
- Contemporary EU AI policy
- Relevance class
- Direct AI relevance
- Policy stage
- Implementation
- Corpus tier
- Directly related
- Sectors
- Policy membership
Classification evidence
- Relevance class: Direct AI relevance · European Commission, Directorate-General for Health and Food Safety · PDF pp.2-5: joint application of AI Act, MDR and IVDR; medical-device AI scope, risks and high-risk qualification. — Substantive AI policy content, not a keyword-only mention.
- Sector tags: Health · European Commission, Directorate-General for Health and Food Safety · PDF pages 2-3, Introduction, and page 5, questions 1-2: AI-based medical devices and the interplay between the AI Act, MDR and IVDR. — Researcher classification grounded in the cited substantive sector scope.
- Provenance tags: Joint institutional · European Commission, Directorate-General for Health and Food Safety · Cover, credits and issuing-body statement. — The cited authorship and institutional roles support this provenance classification; publisher is not automatically author.
- Provenance tags: Authored by an EU expert group · European Commission, Directorate-General for Health and Food Safety · Cover, credits and issuing-body statement. — The cited authorship and institutional roles support this provenance classification; publisher is not automatically author.
- Provenance tags: Officially published · European Commission, Directorate-General for Health and Food Safety · Official publication record and matching manifestation. — Published through the named official EU endpoint.
Production provenance
- Provenance tags
- Named bibliographic authors
- Artificial Intelligence Board · European Commission, Directorate-General for Health and Food Safety · PDF p.1 joint corporate attribution and endorsement statement.
- Medical Device Coordination Group · European Commission, Directorate-General for Health and Food Safety · PDF p.1 joint corporate attribution and endorsement statement.
- Institutions and roles
-
- European Artificial Intelligence Board · Author · role evidence · PDF p.1: Joint Artificial Intelligence Board and Medical Device Coordination Group Document.
- European Commission · Official host · role evidence · DG SANTE official publication endpoint; no author role inferred.
- European Commission · Publisher · role evidence · DG SANTE publication announcement and linked official English file.
- Medical Device Coordination Group · Author · role evidence · PDF p.1: Joint Artificial Intelligence Board and Medical Device Coordination Group Document.
Official sources and identifiers
- Official source · Publisher/host: European Commission, Directorate-General for Health and Food Safety
- Official source · Publisher/host: European Commission, Directorate-General for Health and Food Safety
Research assessment
- Inclusion rationale
- PDF pp.2-5: joint application of AI Act, MDR and IVDR; medical-device AI scope, risks and high-risk qualification.
- Researcher notes
- Cover gives June 2025 only. Exact official publication is the document-date fallback. The Commission hosts the text but its cover explicitly disclaims Commission authorship or position. The initial review left concept coding and policy-group assignment incomplete. Broad policy-group membership was recorded on 12 September 2026; concept-review history remains separate. This editorial grouping does not establish a legal or procedural relationship.
- Review status
- verified
Relationships
No additional published relationships touch this record.
Verification
- Expanded evidence review
- Verified
- Reviewed by
- Yichen Hao
- Evidence review date
- 2026-09-06T22:16:06Z
The evidence review date is not a separate human sign-off date. Review credit and evidence-review actions
- Last verified: 2026-09-06T22:16:06Z · 27-page joint AIB/MDCG document; cover and pp.2-5 inspected. Explicitly not Commission-authored. Inspected capture SHA-256 48db859581fb5f1677068cd4eca770e062c5fcc2a8483d6459daceeb98478626; receipt in research/migrations/2026-09-06-academic-backfill.json. Local bytes retained; no public archive guarantee.
- Last verified: 2026-09-06T22:16:06Z · Publication field and exact linked English file both dated 19 June 2025. Inspected capture SHA-256 d758fb10700023efb4f48f2c27cb79c628eee214cc1ce18496f531f999d0c426; receipt in research/migrations/2026-09-06-academic-backfill.json. Local bytes retained; no public archive guarantee.