Greece

Ministry of Health

Ministry of Health

Regulatory Authority

The National Organization for Medicines (EOF)

Medical Device Regulation

• EU MDR 2017/745
• EU IVDR 2017/746

Official Language

Greek

Classification

Class I, IIa, IIb and III

Registration Process

• Appoint Authorized Representative and Notified Body
• Determine the class of the device.
• Class I device can be Self-Certified. QMS necessary but Notified Body intervention is not required.
• For other classes, prepare a CE Technical File
• Obtain CE Marking certificate.
• Obtain and register UDI in EUDAMED.
• Technical File should be audited by Notified Body.
• Once approved, prepare a Declaration of Conformity.
• The device can now be marketed in Greece.