Resources
Official references and practical checklists for EU and Romania market entry—medical devices (MDR/IVDR), food supplements, and public procurement (SEAP).
EU Medical Devices (MDR / IVDR)
EU MDR (Reg. 2017/745)
Primary legal framework for medical devices placed on the EU market.
EU IVDR (Reg. 2017/746)
Primary legal framework for in vitro diagnostic devices.
EUDAMED actor registration (Actor ID / SRN)
Actor registration enables economic operators to obtain an Actor ID/SRN.
EUDAMED user guides
Process guidance for actor registration and SRN issuance after competent authority validation
Romania (ANMDMR) — market entry pathways for devices
ANMDMR operating permits
Import and distribution activities for medical devices are subject to control through ‘avizare’
Import activity approval guidance
Operational guidance for the import activity approval workflow.
National database registration
ANMDMR states national database registration is not an approval/authorization.
ANMDMR EUDAMED
ANMDMR checks and validates EUDAMED actor requests; following validation SRN is generated.
Food Supplements (EU + Romania) — notification references
Order 1069/2007
Romanian framework approving norms for food supplements
MoH: notified supplements + allowed plants lists
Ministry of Health page listing notifications and resources (incl. plant list).
CRSP / INSP nutrition services
INSP/CRSP provide notification-related services for supplements (category-dependent
Public Procurement (Romania) — SEAP resources
SEAP (e-licitatie.ro) portal
Romania’s public procurement platform (SEAP).
Direct acquisitions list
Catalog/direct acquisitions area (useful for market scanning).
Contract notices
Current contract notices and participation invitations.
ANAP guide (medical devices procurement)
Good-practice guidance for medical devices procurement.
EU scaling and mutual recognition
Regulation (EU) 2019/515