ANMDMR · structured requirements

🇷🇴 Romania medical device regulatory data

Explore the medical device requirements currently available for Romania, organized by topic and linked to official sources.

6 facts5 dimensions5 official sourceslatest verification 2026-08-13

Authority & regime

Which authority and binding regime govern this product, task, and date?

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Competent authority

authority.competent-authority

Official document

National Agency for Medicines and Medical Devices of Romania (ANMDMR)

Legal basis & guidance

Which current law, regulation, guidance, and transition provisions apply?

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Official legal and guidance surface

legal-basis.official-surface

Official document

Authority: National Agency for Medicines and Medical Devices of Romania (ANMDMR)
SubmissionSurface: EUDAMED plus ANMDMR national database forms and email/physical filing
VerifiedHighlights: ANMDMR publishes Word/PDF forms for devices, IVDs, custom-made devices and information changes.
The authority explicitly states that national database registration is not product approval.

Registration pathways

Which registration, notification, listing, reliance, or conformity route applies?

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Market-access route or official registration surface

registration.market-access-route

Official document

SubmissionSurface: EUDAMED plus ANMDMR national database forms and email/physical filing
VerifiedHighlights: ANMDMR publishes Word/PDF forms for devices, IVDs, custom-made devices and information changes.
The authority explicitly states that national database registration is not product approval.

Reliance & recognition

Which foreign decisions or evidence can be reused, with what effect and conditions?

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EU CE under MDR/IVDR — single market validity

reliance.reliance-edge-eu-ce-to-eea30-approval-eu-ce-mdr-ivdr-romania

Official document

Target: geo:rou
SourceApproval: EU CE under MDR/IVDR
EdgeType: Single Market Validity
MarketAccessStrength: direct
RegulatoryLayer: Product Marketing
SameDeviceRequired: Yes
LocalApplicationRequired: No
TargetDecisionRetained: No

Conditions

medical devices and IVDs subject to route-specific scope
valid CE conformity route for the device
country language, economic-operator, EUDAMED, and national vigilance obligations still apply

Türkiye CE under aligned MDR/IVDR — customs union free circulation

reliance.reliance-edge-turkiye-ce-to-eu27-approval-turkiye-ce-mdr-ivdr-romania

Official document

Target: geo:rou
SourceApproval: Türkiye CE under aligned MDR/IVDR
EdgeType: Customs Union Free Circulation
MarketAccessStrength: Direct With Local Obligations
RegulatoryLayer: Product Marketing
LocalApplicationRequired: No
TargetDecisionRetained: No

Conditions

medical devices and IVDs subject to route-specific scope
certificate duly issued by a Turkish notified body under aligned MDR/IVDR rules

UDI, listing & traceability

Which UDI, device listing, database, and traceability duties apply?

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Official UDI or listing surface

udi.official-listing-surface

Official document

SubmissionSurface: EUDAMED plus ANMDMR national database forms and email/physical filing
VerifiedHighlights: ANMDMR publishes Word/PDF forms for devices, IVDs, custom-made devices and information changes.
The authority explicitly states that national database registration is not product approval.

Need to apply Romania's requirements to a product?

Confirm the current ANMDMR pathway, evidence, and local-role details for the actual device before filing.

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