Purpose
MDR and IVDR are the two core EU regulations represented here for medical devices and in-vitro diagnostics.
Choose the relevant branch →Needle EU · independent research demonstration
Medical-device legislation
Two core Regulations shape how medical devices and in-vitro diagnostics reach and stay on the EU market — covering conformity before entry, MDR clinical investigations, IVDR performance studies, supply-chain duties, traceability and post-market monitoring. Start with the product branch, then use the timeline and law map to see how the framework fits together.
At a glance
What matters before you go deeper
These are orientation points from the sources already represented on this page, not a personal applicability decision.
Current state
MDR generally applies since 26 May 2021 and IVDR since 26 May 2022. The first four EUDAMED modules became mandatory on 28 May 2026.
See the typed timeline →Change and upcoming state
Regulation (EU) 2024/1860 changed transition, supply-interruption and EUDAMED rules. COM(2025) 1023 was still a proposal at the 28 Sep 2026 evidence checkpoint.
See enacted and proposed changes →Roles
Manufacturers, authorised representatives, importers and distributors carry different duties. Roles can overlap and this page does not assign one to you.
Compare represented roles →Evidence and depth
Official sources, transition warnings and coverage limits stay visible. Deeper act pages keep source versions, typed dates and legal relationships separate.
Open official evidence →Start here
Which core rule is the starting point?
Product and intended purpose drive the branch. This is orientation, not a personal legal determination.
MDR
Regulation (EU) 2017/745
Medical devices
Medical devices for human use, accessories, and some Annex XVI products without an intended medical purpose when the Regulation's conditions apply.
Boundary: IVDs fall under the IVDR; other exclusions can matter.
IVDR
Regulation (EU) 2017/746
In-vitro diagnostics
IVDs for human specimens, accessories and performance studies, based on the manufacturer's intended purpose.
Lab boundary: general lab or research-use products are outside IVDR unless, in view of their characteristics, the manufacturer specifically intends them for IVD examination.
Time
The framework in six milestones
Application dates, operational milestones and proposals are different things. Spacing is schematic, not proportional to elapsed time.
- Predecessors AIMDD, MDD and IVDD Three directives later replaced by MDR/IVDR, subject to transition effects.
- Core law MDR + IVDR adopted
- Applies MDR generally applies
- Applies IVDR generally applies
- Proposal Further targeted revision proposed
- Operation First four EUDAMED modules mandatory
Transition warning: defined legacy routes can remain available subject to conditions; these milestones do not settle every legacy-device case. The EUDAMED milestone does not mean all six modules are mandatory.
Commission dates and transitions ↗ EUDAMED milestone ↗ Proposal procedure 2025/0404(COD) ↗
Timeline legal detail
MDR replaced Directives 90/385/EEC and 93/42/EEC from its general application date; IVDR replaced Directive 98/79/EC from its general application date, both subject to transition rules. COM(2025) 1023 was still an ongoing proposal at the 28 September 2026 evidence checkpoint.
Structure
How the legislation hangs together
This selected map groups the core acts and shows different kinds of links. It is not a complete legal hierarchy.
EU medical-device framework Editorial grouping, not a legal act
90/385/EEC
93/42/EEC
MDR
Regulation 2017/745
Medical devices
Implementing + delegated act categories
98/79/EC
IVDR
Regulation 2017/746
In-vitro diagnostics
Implementing + delegated act categories
Cross-cutting enacted change
Regulation (EU) 2024/1860 ↗
Amends both MDR and IVDR: transition + EUDAMED + supply-interruption changes
Proposal — not law
COM(2025) 1023 ↗
Targeted revision · procedure 2025/0404(COD), ongoing at the 28 Sep 2026 evidence checkpoint
Selected relationships: the directives are predecessors replaced subject to transition rules; 2024/1860 amends both core Regulations; the lower boxes name categories, not individual acts. The layout is schematic, not a complete act inventory.
Other selected later measures
- Decision (EU) 2025/2371 ↗ — declared the first four EUDAMED systems functional.
- Implementing Regulation (EU) 2026/977 ↗ — notified-body conformity-assessment requirements.
- Delegated Regulation (EU) 2026/1359 ↗ — amends an MDR device-list exception.
- Delegated Regulation (EU) 2026/1451 ↗ — amends an MDR clinical-investigation exception list.
These are examples, not every later measure. See the Commission's wider act overview ↗.
People and organisations
Who carries duties?
You do not have to be the manufacturer. Roles can overlap and this list is not exhaustive.
ManufacturerPrimary conformity system
Designs/manufactures or has the device made and markets it under its name. Maintains risk/evaluation systems, technical documentation and post-market monitoring.
Authorised representativeMandated EU tasks
Acts in the Union under a written mandate for specified tasks for a manufacturer established outside the Union.
ImporterChecks before market placement
Places a device from a third country on the Union market; carries checks plus traceability, cooperation and corrective duties.
DistributorDue-care checks in supply
Makes devices available in the supply chain, with specified checks and duties around complaints, non-conformity and cooperation.
Patients, users, healthcare professionals, health institutions, notified bodies and authorities are also affected, but not as one common “economic operator” role.
Verification
Sources and limits
MDREUR-Lex current access ↗
IVDREUR-Lex current access ↗
FrameworkCommission overview ↗
EUDAMEDCommission overview ↗
This overview does not decide compliance. Complete exclusions, classification, every transition deadline, national rules and personalised applicability remain outside this page.