Medical Device Distributor in Romania (EU MDR-ready)
We support EU market entry via Romania: MDR pathway screening, importer/distributor setup, and compliant go-to-market.
Medical Devices – our capabilties
1
MDR route & compliance screening
- Confirm product route (MDR vs IVDR vs borderline)
- Intended purpose & claims check
- Gap list + required next actions
2
Importer / Distributor setup (EU MDR)
- Importer/distributor role mapping across your supply chain
- Documentation discipline + audit-ready workflows
- Labelling/IFU readiness for “information supplied” obligations
3
Romania execution
- ANMDMR pathway guidance for Romania import/distribution setup
- Local launch support (pharmacies, clinics, tenders, Medical education & KOL engagement)
- Ongoing compliance support post-launch
Sources: ANMDMR guidance (operation permits / EUDAMED actor registration / national database note); Ministry of Health notification framework; IBA notification portal; SEAP (e-licitatie.ro).
EU MDR checks we operationalise for importers and distributors
Under EU MDR, importers and distributors must perform defined checks before placing / making devices available.
Importer checks (EU MDR – practical summary):
- CE mark present + EU Declaration of Conformity exists EUR-Lex
- Manufacturer identified + Authorised Representative designated (when applicable) EUR-Lex
- Label + IFU present as required EUR-Lex
- UDI assigned where applicable EUR-Lex
- Importer identification applied on device/packaging/accompanying document (without obscuring manufacturer info) EUR-Lex
Distributor checks (EU MDR – practical summary):
- Verify CE marking + EU DoC exists EUR-Lex
- Ensure device is accompanied by required manufacturer information EUR-Lex
- Verify importer labelling requirements are met for imported devices EUR-Lex
- Verify UDI assigned where applicable EUR-Lex
Conformity assessment and CE certification remain the manufacturer’s responsibility; we structure importer/distributor controls and evidence packs.
How it works
01 → 02 → 03 → 04 → 05
STEP 01
Regulatory screening
- Confirm product route: Medical Device (MDR)
- Review intended purpose + claims and identify compliance gaps
- Define the economic-operator setup needed for EU market entry (importer/distributor model)
Output: Regulatory screening memo + gap checklist
STEP 02
Documentation & labelling readiness
- Align technical/commercial documentation to the applicable route (MDR/IVDR )
- Prepare label/IFU readiness including Romanian language where required for the local launch
- Ensure information supplied with devices follows Member State language rules (as applicable)
Output: Label/IFU pack + claims alignment notes
STEP 03
Romania authorisations & notifications
Medical devices
- Support for ANMDMR/NAMMDR operating approvals for import/distribution activity in Romania
- EUDAMED economic operator registration workflow: submission → authority validation → SRN issued
Output: Romania approval/notification dossier pack
STEP 04
Commercial launch in Romania
- Channel rollout: pharmacy chains + independents + compliant e-commerce + Medical education & KOL engagement
- Marketplace readiness (correct listings, compliant claims, traceability)
- Hospital/tender readiness where relevant (documentation discipline + procurement execution)
Output: Launch plan + compliant listings pack
STEP 05
Scale into other EU markets
- Medical devices: EU scaling is driven by MDR/IVDR compliance plus Member State requirements (notably language requirements for IFU/labeling).
- Mutual recognition (Reg. (EU) 2019/515): relevant mainly for non-harmonised/partly harmonised goods; we assess applicability case-by-case and document the rationale.
Output: EU expansion plan (markets, requirements, sequencing)