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 of Medical Devices
Class I, IIa, IIb and III
Registration Process
1. Determine the device classification
2. Appoint an Authorized Representative and Notified Body
3. The medical devices must be registered in the NAMMD database
4. For class, I, custom-made and System packs – NAMMD registration should be made by the manufacturer or authorized representative
5. For Class II, III, IVDs and active implantable – NAMMD notification should be submitted within 3 months of the medical device putting into service.
Documents Required
1. Application Form
2. CE certificate
3. Declaration of Conformity
4. Technical File
5. QMS Certificate
6. Labels, IFU
7. Letter of Authorization for Authorized Representative
8. Conformity Assessment Report from Notified Body
Post-Market Surveillance
Adverse event report,
1. Serious public health threats – 2 day
2. Death or serious health deterioration – 10 days
3. Other serious incidents – 15 days
Applicable QMS
ISO 13485
Authorized Representative
Yes
License Validity
Years
Special Notes
Record of medical devices in the national database is free of charge
