EOF market access

Greece medical device registration resources

Research EOF registration records, classification, regulations, timelines, fees, and market updates — the stable entrance to every Greece medical device resource.

5 free resources23/25 requirements coveredAug 2026 fees reviewed

Run the classification agent

Everything we track for Greece

Browse by resource instead →

Medical device regulation news

Follow recent National Organization for Medicines (EOF) policy, guidance, safety, and compliance updates.

AI medical device classifier

Describe your device and get a preliminary EOF risk class with official rule references.

Government registration fees

Review current EOF application, review, and renewal fees.

Additional certification and licence checker

Check whether product features may trigger separate radio, electrical, metrology, radiation, import, or other Greece requirements.

Registration timeline

Compare the statutory notified-body conformity assessment clock under Regulation (EU) 2026/977 with realistic CE marking times by device class.

Structured regulatory requirements

Explore all 37 source-linked facts →

23 of 25 research dimensions currently covered · 27 official sources · latest verification 2026-09-07

Market entry

D01

Authority & regime

Verified

Competent authority: EOF (National Organization for Medicines, Εθνικός Οργανισμός Φαρμάκων) is the national competent authority for medical devices and IVDs and the authority for the application of Regulations…
EOF unit responsibilities for devices: Within EOF: Τμήμα Αξιολόγησης Υγειονομικού Υλικού (Διεύθυνση Αξιολόγησης Προϊόντων) handles registration/notification; Τμήμα Κλινικών Δοκιμών handles clinical investigations; Τμήμα Ανεπιθύμ…

2 source-linked facts

Checked 2026-08-25

Open details →

D02

Legal basis & guidance

Verified

National harmonization framework: Greek national device framework: ΔΥ8δ/Γ.Π.οικ130648/ΦΕΚ Β' 2198/02 10 2009 (MDD harmonization), ΔΥ8δ/Γ.Π.οικ130644/ΦΕΚ Β' 2197/02 10 2009 (AIMD), ΔΥ8δ/οικ3607/892/ΦΕΚ Β' 1060/10 08 2001 (IV…
Official legal and guidance surface: authority: National Organization for Medicines (EOF) · submissionSurface: EUDAMED plus EOF national medical device register (GREMDIS, services.eof.gr/gremdis) and EOF forms for applicable n…

2 source-linked facts

Checked 2026-08-25

Open details →

D03

Device definition & scope

Verified

Borderline: camphor/menthol topical products are not devices: By EOF Presidential Decision 91092/01 09 2023, skin applied products with health claims (muscle/joint pain etc.) containing camphor and/or menthol may not be placed on the Greek market as m…

1 source-linked fact

Checked 2026-08-25

Open details →

D04

Classification rules

Verified

EU MDR classes I, Is, Im, Ir, IIa, IIb and III: Class I, Class Is, Class Im, Class Ir, Class IIa, Class IIb, Class III

1 maintained scheme

Checked 2026-08-26

Open details →

D05

Registration pathways

Verified

National manufacturers' register (Class I / custom-made / IVD): Manufacturers with seat in Greece placing devices on the Greek market under their own name, and Greek authorized representatives of manufacturers outside the EU, must register in the EOF El…
Device notification by importers/distributors to GREMDIS: Importers/distributors of medical devices must, before placing devices on the Greek market, notify the device data to the National Electronic Register of Medical Devices (Εθνικό Ηλεκτρονικό…

3 source-linked facts

Checked 2026-08-25

Open details →

D06

Reliance & recognition

Verified

EU CE under MDR/IVDR — single market validity: target: geo:grc · sourceApproval: EU CE under MDR/IVDR · edgeType: single market validity · marketAccessStrength: direct · regulatoryLayer: product marketing · sameDeviceRequired: Yes · loc…

1 source-linked fact

Checked 2026-08-30

Open details →

D07

Economic-operator roles

Verified

Distributor charter requirement and GDP certificate: A company distributing medical devices in Greece must include 'Εμπορία Ι/Π' (trade in medical devices) in its corporate charter purpose and hold a medical device distribution certificate (β…

1 source-linked fact

Checked 2026-08-25

Open details →

D08

Establishment, import & distribution

Verified

Production capability licence (Άδεια Δυνατότητας Παραγωγής): EOF administers national establishment licences for device production: granting of the 'Άδεια Δυνατότητας Παραγωγής Ιατροτεχνολογικών Προϊόντων' (EOF Circular 3172/14 01 2011), transfer of…
National good distribution practice decision: Ministerial Decision ΔΥ8δ/Γ.Π.οικ./1348 (ΦΕΚ Β' 32/16 01 2004) sets national principles and guidelines of good distribution practice for medical devices ('Αρχές και κατευθυντήριες γραμμές ο…

2 source-linked facts

Checked 2026-08-25

Open details →

D09

Dossier requirements

Verified

Register application documents: Dossier for registration (new, supplementary or renewal) in the EOF Manufacturers' Register: business licence (Άδεια Ασκήσεως Επαγγέλματος), company legalization documents, Declaration of C…

1 source-linked fact

Checked 2026-08-25

Open details →

D10

Official forms & portals

Verified

Official form or portal surface: submissionSurface: EUDAMED plus EOF national medical device register (GREMDIS at services.eof.gr/gremdis) and EOF forms for applicable national duties · verifiedHighlights: EOF publishes cu…
National clinical investigation / performance study forms: EOF publishes Greek language application forms for the Special Part of initial applications (DFME E4800 1 2 'Αρχική Αίτηση διεξαγωγής κλινικής έρευνας ή μελέτης επιδόσεων υπό τον MDR ή IVDR…

2 source-linked facts

Checked 2026-08-25

Open details →

Submission & evidence

D11

Label, IFU & language

Verified

Greek language for labelling and IFU: Before devices are placed in circulation on the Greek market, the labelling and the instructions for use must be complete and accurate in the Greek language at delivery to the final user; u…
English accepted for professional-use devices (Circular 37580/2025): EOF Circular 37580/31.03.2025 accepts the use of the ENGLISH language in the Instructions for Use/user manual, the labelling and the software of medical devices placed on the Greek market,…

2 source-linked facts

Checked 2026-08-25

Open details →

D12

QMS, audit & inspection

Verified

National GMP specifications for medical aids: EOF Board Decision 6209/2009 (ΦΕΚ Β' 199/06.02.2009) sets specifications of Good Manufacturing Practice rules for medical aids ('Προδιαγραφές Κανόνων Καλής Παραγωγής Ιατρικών Βοηθημάτων');…

1 source-linked fact

Checked 2026-08-25

Open details →

D13

Standards, testing & ancillary approvals

Unresolved

MDR electrical safety in place of the Low Voltage Directive: Electrical safety
MDR electromagnetic compatibility in place of the EMC Directive: EMC
Presidential Decree 98/2017 radio equipment market access: Wireless / radio

8 maintained overlays

Checked 2026-09-07

Open details →

D14

Fees

Verified

Register application fee (devices and IVDs): EUR 200–1,000
Fee per additional packaging/size: EUR 10

5 maintained fee lines · 1 related fact

Checked 2026-08-25

Open details →

D15

Review clocks

Unresolved

Class I · Self-declaration (no notified body): 0 days

1 maintained pathway · 1 related fact

Checked 2026-08-29

Open details →

D16

Approval validity & renewal

Verified

Register renewal and 5-year fee window: The EOF national register operates with renewal (ανανέωση/επαναεγγραφή) applications: no new fee (παράβολο) is due if less than five years (πενταετία) have elapsed since the last registrati…

1 source-linked fact

Checked 2026-08-25

Open details →

Lifecycle & post-market

D17

Change control

Verified

Register certificate modifications: Each request for modification of EOF register certificates (βεβαιώσεις) requires submission of a modification application with a fee (παράβολο) of EUR 100 (plus 2.4% stamp duty per the 2022…
Substantial modification of a clinical investigation: A substantial modification (ουσιώδης τροποποίηση) of an EOF approved clinical investigation requires a new application following the same dossier structure (General Part per Annex XV Ch. II…

2 source-linked facts

Checked 2026-08-25

Open details →

D18

UDI, listing & traceability

Verified

Official UDI or listing surface: submissionSurface: EUDAMED plus EOF national medical device register (GREMDIS, services.eof.gr/gremdis) for applicable national duties · verifiedHighlights: EOF publishes current medical de…

1 source-linked fact

Checked 2026-08-25

Open details →

D19

Clinical investigation & performance

Verified

Art. 62 clinical investigations submitted to EOF: Clinical investigations under Article 62 MDR are submitted to EOF for evaluation and approval. The dossier = cover letter (with contents list and Greek budget summary) + General Part per An…
Art. 74(1) notification 30 days before start, no fee: Clinical investigations under Article 74(1) MDR require notification to EOF at least 30 days before the start of the clinical investigation in Greece (dossier: cover letter with justificati…

4 source-linked facts

Checked 2026-08-25

Open details →

D20

Special access & derogation

Verified

In-house health-institution exemption (Art. 5(5)): Devices manufactured and used only within health institutions established in the Union are exempt from the requirements of the Regulation, with the exception of the relevant general safety…

1 source-linked fact

Checked 2026-08-29

Open details →

D21

Manufacturer PMS

Verified

Post-market surveillance reporting (Arts. 83-86): Manufacturers must implement a post market surveillance system (Art. 83) and a documented post market surveillance plan proportionate to the risk class and appropriate to the type of device…

1 source-linked fact

Checked 2026-08-29

Open details →

D22

Vigilance & incident reporting

Verified

Manufacturer incident reporting to EOF (2/10/30 days): Manufacturers must report to EOF all serious incidents occurring within Greek territory of which they become aware in any way; initial reports (Initial Report, MIR form in English per MEDDE…
User reporting via White Card (Λευκή Κάρτα): Health professional users (medical bodies/medical institutions) are obliged to notify EOF of all serious incidents that come to their attention from use of medical devices in Greece; patien…

3 source-linked facts

Checked 2026-08-25

Open details →

D23

Recall, FSCA & market surveillance

Verified

FSCA two-phase reporting to EOF with Greek FSN: Before implementing a field safety corrective action (FSCA) the manufacturer must send EOF: (1) nominal list of customers to be informed with full contact details, (2) description of the pr…

1 source-linked fact

Checked 2026-08-25

Open details →

D24

Advertising, claims & promotion

Verified

EOF promotional-material submission applies to medicines only: EOF's cited promotional/informational material submission regime (submission to the Τμήμα Ελέγχου Κυκλοφορίας under Article 130(2) of ΚΥΑ Δ.ΥΓ3α/Γ.Π. 32221/2013) applies to human pharmaceut…

1 source-linked fact

Checked 2026-08-25

Open details →

D25

Submission communications & appeal

Verified

Reasoned individual act and applicant document duty: An individual administrative act of EOF, including a refusal or other adverse device decision, must contain reasoning that records the statutory conditions for issuing it (Law 2690/1999 Art…
Notice of the special administrative or ενδικοφανής appeal on the individual act: An individual administrative act must also state whether a special administrative or ενδικοφανής appeal under Art. 25 of Law 2690/1999 is available, name the body that examines it, state th…

2 source-linked facts

Checked 2026-08-30

Open details →

Government fees

Full fee schedule (5 lines) →

EOF registration fees in EUR · reviewed 2026-08-25

Fee line	Amount	Provenance
Register application fee (devices and IVDs)	EUR 200–1,000	Verified
Fee per additional packaging/size	EUR 10	Verified
Modification of registered data	EUR 100	Verified
Clinical-investigation initial application	EUR 1,000	Verified