Purpose
EU rules for placing on the market, making available or putting into service medical devices for human use and accessories, plus clinical investigations in the Union.
Open scope →Core act · source-bounded orientation
MDR
Medical Device Regulation
Regulation (EU) 2017/745
EU rules for placing on the market, making available or putting into service medical devices for human use and accessories, plus clinical investigations 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 2021.
See typed dates →What changed
Represented later changes include Regulation (EU) 2023/607, 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 2028, 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
- Medical devices for human use and accessories are the core material scope.
- Selected Annex XVI products without an intended medical purpose enter the MDR when the Regulation's Article 1 conditions and applicable common specifications are met.
- In-vitro diagnostic devices belong to the IVDR branch; this page does not infer a reader's product 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, conformity-system, 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 device on the Union market.
Distributor
Due-care and specified checks when making devices 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 MDR application date; Article 123 contains provision-specific derogations.
- AMENDMENT APPLICATIONSupply-interruption duty applies
Regulation (EU) 2024/1860 inserted Article 10a; the relevant amendment applies from 10 January 2025.
- OPERATIONAL TRIGGERFirst four EUDAMED modules mandatory
An operational milestone triggered under the gradual-roll-out rules; it does not mean all six modules are mandatory.
- FUTURE TRANSITIONSelected legacy transition
Eligible class III and certain class IIb implantable legacy devices may use the amended transition route through this date, subject to Article 120 conditions.
- FUTURE TRANSITIONSelected legacy transition
Other eligible class IIb, class IIa and specified class I legacy devices may use the amended transition 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.
- REPLACESDirectives 90/385/EEC and 93/42/EEC
Replaced from the MDR regime subject to transition provisions.
- AMENDED BYRegulation (EU) 2023/607
Changed selected MDR transition provisions and removed the former sell-off deadline.
- AMENDED BYRegulation (EU) 2024/1860
Added supply-interruption duties and gradual EUDAMED roll-out changes; also amended IVDR.
- 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.