Purpose
EU rules for placing on the market, making available or putting into service in-vitro diagnostic medical devices for human use and accessories, plus performance studies in the Union.
Open scope →Core act · source-bounded orientation
IVDR
In Vitro Diagnostic Medical Device Regulation
Regulation (EU) 2017/746
EU rules for placing on the market, making available or putting into service in-vitro diagnostic medical devices for human use and accessories, plus performance studies in the Union.
At a glance
What matters before the detail
Summary of the same represented act data below; it does not determine a reader's role or applicability.
Current state
In force. General application date: 26 May 2022.
See typed dates →What changed
Represented later changes include Regulation (EU) 2022/112, Regulation (EU) 2024/1860, Decision (EU) 2025/2371. Relationship labels below distinguish amendments from operational triggers.
See legal connections →Roles represented
Manufacturer, Authorised representative, Importer, Distributor. Roles can overlap; this page does not assign one to you.
Compare role summaries →Upcoming state
Selected legacy-transition milestones shown below extend through 31 Dec 2029, subject to the stated conditions.
Inspect transitions →Evidence and depth
Source version, official act links and limits remain explicit below.
Open official evidence →Purpose and scope
What this act covers
- In-vitro diagnostic medical devices for human use, their accessories and performance studies are the core material scope.
- General laboratory-use and research-use-only products are outside Article 1 unless, in view of their characteristics, the manufacturer specifically intends them for in-vitro diagnostic examination.
- Where a product incorporates an MDR medical device as an integral part, Article 1 keeps the MDR/IVDR parts distinct; this page does not infer a reader's classification.
This is selected orientation. Classification, every exclusion, national rules and personal applicability require the full sources and facts.
Economic-operator orientation
Represented roles
Manufacturer
Primary design/manufacture, performance-evaluation, documentation and post-market responsibilities.
Authorised representative
Mandated Union tasks for a manufacturer established outside the Union; the mandate is bounded.
Importer
Specified checks and traceability duties before placing a third-country IVD on the Union market.
Distributor
Due-care and specified checks when making IVDs available in the supply chain.
Roles can overlap. These summaries do not determine which role a reader occupies and are not complete obligation lists. Follow the article source below.
Time
Current state and selected transitions
Dates are typed by legal function. A future transition is not shown as current state, and a general application date does not replace provision-specific dates.
- ADOPTIONAdopted
Regulation adopted; this is not the same as its general application date.
- ENTRY INTO FORCEEntered into force
Twenty days after Official Journal publication.
- GENERAL APPLICATIONGenerally applies
The general IVDR application date; Article 113 contains provision-specific derogations.
- AMENDMENT EFFECTIVDR transition amendment in force
Regulation (EU) 2024/1860 entered into force on publication and amended the IVDR legacy transition framework.
- AMENDMENT APPLICATIONSupply-interruption duty applies
Article 2(1) of Regulation (EU) 2024/1860 inserts IVDR Article 10a; Article 3 makes that point applicable from 10 January 2025.
- OPERATIONAL TRIGGERFirst four EUDAMED modules mandatory
An operational milestone; the two remaining modules were still under development at the evidence check.
- FUTURE TRANSITIONClass D legacy transition
Eligible legacy class D devices may use the amended route through this date, subject to Article 110 conditions.
- FUTURE TRANSITIONClass C legacy transition
Eligible legacy class C devices may use the amended route through this date, subject to conditions.
- FUTURE TRANSITIONClass B / sterile A legacy transition
Eligible class B and class A sterile legacy devices may use the amended route through this date, subject to conditions.
Relationships
Selected legal connections
Relationship labels describe the represented legal connection; visual proximity is not an impact inference.
- REPLACESDirective 98/79/EC
Replaced from the IVDR regime subject to transition provisions.
- AMENDED BYRegulation (EU) 2022/112
Introduced an earlier staggered transition for selected legacy IVDs.
- AMENDED BYRegulation (EU) 2024/1860
Further extended selected IVDR transitions and added supply-interruption/EUDAMED changes; also amended MDR.
- OPERATIONAL TRIGGERDecision (EU) 2025/2371
Declared the first four represented EUDAMED systems functional, leading to mandatory use from 28 May 2026.
Verification
Official sources and next paths
Original actOfficial EUR-Lex text ↗Article textVersioned consolidation ↗Transition/amendment sourceOfficial amending act ↗2024/1860Cross-cutting amendment ↗EUDAMED triggerDecision (EU) 2025/2371 ↗EUDAMED statusCommission overview ↗
This page does not decide compliance. It is a selected, evidence-dated explanation of the represented EU-level act.