Medical Device Registration in

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.

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

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