Official
Competent authority
National authority responsible for medical-device oversight.
2 linked sources
ANMDMR · official source indexRomania medical device regulatory sources
Start with the competent authority, submission surface, official forms, and source coverage we have verified for Romania.
8 dimensions sourced5 official sources2026-08-13 reviewed
Official starting point
National Agency for Medicines and Medical Devices of Romania (ANMDMR)
EUDAMED plus ANMDMR national database forms and email/physical filing
Coverage boundary
This is an official-source spine, not a completed market-access rulebook. It identifies where to begin and shows which dimensions still need detailed extraction.
Structured coverage
Nine regulatory research dimensions
Each status is source-bound. A located page is useful for research, but it does not turn adjacent requirements into verified facts.
Shared + national
Legislation & guidance
Primary law, regulation, or official implementation guidance.
3 linked sources
Official
Registration & submission
Official route used to register an operator or submit a device.
4 linked sources
Official
Official forms
Current authority forms, filing templates, or online form surface.
3 linked sources
Official
Label, IFU & language
Official surface for labeling, instructions for use, and language rules.
3 linked sources
Official
UDI & traceability
Official UDI, device identification, or traceability surface.
4 linked sources
Research needed
Post-market & vigilance
Incident reporting, vigilance, safety action, and recall surface.
0 linked sources
Official
Import & establishment
Importer, local operator, establishment, or market-entry surface.
3 linked sources
Official
Renewal & change
Renewal, variation, amendment, transfer, or discontinuation surface.
3 linked sources
Source highlights
What the reviewed surfaces indicate
- 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.
Primary evidence
Official sources
European Commission
Medical devices — national competent-authority contacts
Current EU competent-authority discovery and contact spine.
EUR-Lex
Regulation (EU) 2017/746 on in vitro diagnostic medical devices
Shared EU/EEA IVD rule layer; national implementation deltas remain separate.
EUR-Lex
Regulation (EU) 2017/745 on medical devices
Shared EU/EEA medical-device rule layer; national implementation deltas remain separate.
European Commission
EUDAMED information centre
Shared EUDAMED layer; mandatory use of the first four modules began 28 May 2026.
National Agency for Medicines and Medical Devices of Romania (ANMDMR)
Registration of medical devices in the national database
Current official surface used as a bounded starting point; it is not a complete rule table.
Official source indexes in other markets
Other Europe markets
Austria
Belgium
Bulgaria
Czech Republic
Denmark
Finland
France
Germany
Greece
Hungary
Ireland
Italy
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