Romania

Ministry of Health:     

Ministry of Health

Regulatory Authority:          

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

Medical Device Regulation:          

EU MDR 2017/745

EU IVDR 2017/746

Official Language:      

Romanian

Classification:    

Class I, IIa, IIb and III

Registration Process:

• Determine the device classification
• Appoint an Authorized Representative and Notified Body
• The medical devices must be registered in the NAMMD database
• For class, I, custom-made and System packs – NAMMD registration should be made by the manufacturer or authorized representative
• For Class II, III, IVDs and active implantable – NAMMD notification should be submitted within 3 months of the medical device putting into service.