Overview of the National Organisation for Medicines (EOF) and Medical Device Regulation in Greece

National Organisation for Medicines (EOF) - Medical Devices Overview

The National Organisation for Medicines (EOF) (Greek: Εθνικός Οργανισμός Φαρμάκων) is a public entity under the Ministry of Health of the Hellenic Republic. Founded in 1983, EOF acts as the national competent authority responsible for protecting and promoting public health by ensuring that medical devices, pharmaceuticals, and other health products marketed in Greece fulfill strict compliance criteria.

Key Roles and Responsibilities

EOF manages the enforcement of technical and clinical legal mandates regarding medical devices via the following core functions:

• Notification & National Registry: Coordinates the entry of medical devices into the national GreMDIS electronic database. Local manufacturers, authorized representatives, and distributors must notify EOF before placing products (including Class I, IIa, IIb, III, and IVD devices) onto the Greek market.
• Market Surveillance: Conducts regular and unannounced facility inspections, laboratory audits, and checks on economic operators to confirm compliance with technical files and production certificates.
• Materiovigilance (Vigilance System): Serves as the central node for reporting serious adverse events, device malfunctions, and evaluating Field Safety Corrective Actions (FSCAs) issued by manufacturers to mitigate safety risks quickly.
• Clinical Investigations: Reviews, approves, and supervises clinical trials and investigations for medical devices carried out within Greek healthcare institutions.

Regulatory Framework

EOF alignment follows the standardized requirements of the European Union:

• Medical Device Regulation (MDR) - Regulation (EU) 2017/745
• In Vitro Diagnostic Regulation (IVDR) - Regulation (EU) 2017/746
• National implementation acts and Ministerial Decisions (such as DY8d/oik.1348/2004 for medical device distribution standards).