Current core · MDR
Medical Devices Regulation
Regulation (EU) 2017/745
Scope: medical devices for human use and accessories; also specified Annex XVI product groups when the Regulation's conditions apply.
Official MDR sourceNeedle EU · independent research demonstration
Medical-device relationships
Three predecessor directives were replaced by two current core regulations, with later transition, implementation, EUDAMED and guidance layers around them.
← Return to medical-device overviewThese controls change this page’s task view. Research diagnostics opens maintenance detail; it is not a site-wide Expert setting.
Overview
See the regime before reading the detail
90/385/EECActive implantable devicesReplaced by MDR ↓
93/42/EECMedical devicesReplaced by MDR ↓
98/79/ECIn-vitro diagnosticsReplaced by IVDR ↓
Current core · IVDR
In Vitro Diagnostic Medical Devices Regulation
Regulation (EU) 2017/746
Scope: in-vitro diagnostic medical devices for human use and accessories; performance studies are also within scope.
Official IVDR sourceTransition matters: replacement does not make every predecessor effect vanish immediately; transitional rules preserve some effects for bounded cases.
Browse represented layers
What hangs from the core regime?
- Implementing measuresMDR, IVDR or both · 17 listed in the frozen Commission overview
- Delegated actsMDR and IVDR layers · 7 listed in the frozen overview
- EUDAMED / system operationCross-branch operational and transition triggers
- Non-binding guidanceImplementation guidance, kept distinct from legislation
Current context
Two things not to collapse
Enacted change: Regulation (EU) 2024/1860 amends both MDR and IVDR around EUDAMED, supply information and IVDR transition.
Proposal — not enacted: COM(2025) 1023 is represented separately from current law.
MDR 2017/745
+
IVDR 2017/746
Evidence 27 Sep 2026
Explore
Browse one represented layer at a time
Navigation groupings help you browse. Individual rows keep their own legal relationship and branch meaning.
Showing representative implementing measures across the whole regime.
Implementing measures
17 unique acts listed in the frozen Commission overview; six representative rows shown here.
-
MDR legal basis2021/2078sets EUDAMED arrangementsOfficial source
Why?
Adopted under MDR Article 33(8). EUDAMED itself serves the wider MDR/IVDR system.
Internal relation state: implementing/system dependency.
-
IVDR2022/1107common specifications · class D IVDsOfficial source
Why?
Implements common specifications for specified class D in-vitro diagnostic devices under IVDR.
-
MDR2022/2346common specifications · Annex XVI productsOfficial source
Why?
MDR-side common specifications for Annex XVI product groups.
Additional amendment: 2023/1194 amends its transitional provisions and is not expanded as a normal child in this bounded sample. Open amendment.
-
IVDR2023/2713EU reference laboratoriesOfficial source
Why?
Designates EU reference laboratories for specified high-risk IVD functions under IVDR.
-
MDR + IVDR2026/977notified-body / conformity-assessment requirementsOfficial source
Why?
Uses legal bases in both MDR and IVDR for notified-body application/designation requirements.
-
MDR basis · IVDR tasks too2019/1396 → 2025/1324expert-panel designation and amendmentOfficial source
Why?
The implementing-decision basis is MDR Article 106; the expert-panel structure also performs specified IVDR tasks.
Delegated acts
Representative expansion only; 7 unique delegated/delegated-amending regulations are listed in the frozen Commission overview.
-
MDR2023/2197 → 2025/788UDI assignment · contact lensesOfficial source
Why?
2023/2197 amends MDR UDI rules for highly individualised contact lenses; 2025/788 changes its application date.
-
MDR2023/502notified-body reassessment frequencyOfficial source
Why?
Amends MDR rules on complete reassessment frequency for notified bodies.
-
MDR2026/1451clinical-investigation exemption listOfficial source
Why?
Amends the MDR list relevant to clinical-investigation exemptions.
Representative sample: the official overview also includes IVDR delegated acts. Delegated Regulation 2023/503 is one verified IVDR example outside this expansion. Open 2023/503.
Transition / later change
Branch-specific changes grouped for navigation; each row keeps its own branch meaning.
- MDR2020/561amends MDR application dates
- IVDR2022/112amends IVDR transition
- MDR + IVDR2023/607amends transitional provisions
- MDR + IVDR2024/1860EUDAMED, supply information and IVDR transition
EUDAMED / system operation
A cross-cutting navigation lens. Repeated acts are cross-references, not extra instruments.
- MDR legal basis2021/2078sets EUDAMED arrangements
- MDR + IVDR2025/2371declares first four modules functionalOfficial source
Why?
Functionality triggers transition mechanics tied to provisions in both regimes; the Commission states the first four modules became mandatory from 28 May 2026.
Non-binding guidance
Useful implementation context, kept textually distinct from legislation.
- MDR · non-bindingMDCG 2021-25 rev.1legacy-device transition guidanceOfficial guidance page
Why?
MDCG guidance presents a common implementation understanding but is not legally binding.
MDR 2017/745+IVDR 2017/746Evidence 27 Sep 2026
Change review
What should be re-opened after this change?
A review candidate is not a conclusion that legal effect changed.
Showing review queue for Regulation (EU) 2024/1860.
Regulation (EU) 2024/1860Directly amends MDR and IVDR
Official source
- Review directlyMDR current-state explanationArticle 1 directly amends MDR.
Why?
Internal state:
DIRECT_REVIEW. Re-check represented EUDAMED and supply-interruption wording against the amended MDR provisions. - Review directlyIVDR transition explanationArticle 2 directly amends IVDR, including transition.
Why?
Internal state:
DIRECT_REVIEW. Re-check IVDR transition and EUDAMED-linked wording. - Review directlyJoint transition/change relationThe displayed relationship itself describes this amending act.
- Review downstreamEUDAMED system stateThe amendment changes gradual rollout mechanics.
Why?
Internal state:
DOWNSTREAM_REVIEW. Continue only through a verified EUDAMED/provision dependency. - ContextDecision 2025/2371Later functionality event already represented at this evidence date.
- Stop hereUnrelated child familiesFamily membership alone is not a dependency.
Why?
Internal state:
NO_PROPAGATION. No represented provision-specific edge continues into common-specification, reference-lab, delegated or expert-panel children.
Decision (EU) 2025/1324Directly amends the expert-panel decision
Official source
- Review directlyDecision 2019/1396 expert-panel nodeThe upstream decision expressly amends it.
Why?
Internal state:
DIRECT_REVIEW. - Review directly“amended by 2025/1324” relationThe maintained mutation edge must match the amending act.
- Stop hereMDR / IVDR core and unrelated familiesNo second verified dependency continues downstream.
Why?
Internal state:
NO_PROPAGATION. Expert-panel tasks touching both regimes do not make every neighboring claim dependent on the changed provisions.
Regulation (EU) 2023/1194Known amendment outside the normal child expansion
Official source
- Review directlyRegulation 2022/2346 node2023/1194 directly amends its transitional provisions.
- ContextMDR coreParent legal context; it is not itself amended by 2023/1194.
- Outside sample2023/1194 graph nodeKnown source control; no need to ingest it as a normal child to trigger review.
Why?
Internal state:
OUT_OF_SCOPE. - Stop hereNo represented downstream childNo further typed dependency continues from 2022/2346 in this slice.
Medical-devices projectionEvidence 27 Sep 2026Research layer
Research diagnostics
Projection diagnostics
Maintenance and evidence-quality signals for this bounded projection—not findings that EU law is defective.
- Coverage omission2022/2346 has an amendment outside the normal expansionOfficial source identifies 2023/1194.Source
- Branch coverageIVDR delegated example outside representative expansion2023/503 is a verified positive control.Source
- Transition triggerEUDAMED functionality event represented/reviewedDecision 2025/2371 is not an unresolved gap.Source
- Structural-gap candidateNone assertedIncomplete graph coverage cannot prove legal absence.
Threshold
Requires a mandatory expectation, identifiable downstream measure, sufficiently complete official-source search, and no evidence the requirement was satisfied another way.
Research boundary and signal definitions
Coverage means an official source positively identifies something outside this slice. Review needs a real upstream change and a maintained dependent claim. Structural absence fails closed unless the evidence can support an expected-but-unidentified downstream measure.