Medical Device Registration in
Greece
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
Medical Device Registration in Greece
- 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.
Documents Required
- CE Certificate
- Technical File
- Declaration of Conformity
- Clinical Evaluation Report (CER)
- Risk Management File
- QMS certificate
- Labelling
Post-market Requirements
Adverse event report,
- Serious public health threats – 2 day
- Death or serious health deterioration – 10 days
- Other serious incidents – 15 days
Applicable QMS
ISO 13485
Registration Timeline
4 – 6 weeks
Others – Based on the Notified Body
Authorized Representative
Yes
License Validity
5 years
Special Notes
IFUs and Labels must be in Greek