| Regulatory Authority | Greek National Organization for Medicines (EOF) |
|---|---|
| Regulatory Authority Website Link | Click Here |
| Device Classification | I, IIa, IIb and III |
| Medical Device Regulations | EUMDR-2017/745 | Click Here |
| IVD Classification | A,B,C,D |
| In Vitro Diagnostics Regulations | (EU) 2017/746 | Click Here |
| Registration Process | Procedures and supporting documents | Click Here |
| Registration Timeline | For Class I, it is 1 to 2 months and for other classes, it depends on the notified body and type of product |
| Requirement of Authorized Representative | Yes |
| Language Requirement | Labels must be in Greek Language |
| Database | GREMDIS | Click Here |
| Adverse Event Reporting Form | Download |
| Additional Information | For all medical devices placed on the Greek market, Manufacturers or their EC-Authorized Representatives are required to submit to the National Organization for Medicines, all data allowing for the identification of such devices together with the label and the instructions for use when such devices are placed on the market and are put into service in Greece. The required documents are the following: 1. Declaration of Conformity by the Manufacturer 2. CE Certificate / certificate of registration to a Competent Authority (for low risk devices) 3. Instructions for Use 4. Labels |