Greece Medical Device Registration

Medical Device Registration in Greece: Navigating Regulatory Requirements with EOF

Updated on 26/01/24

Regulatory Authority: National Organization for Medicines (EOF)

The National Medicines Organization (EOF), established in 1983, protects public health in Greece regarding pharmaceutical products, medicated feed, diet foods, supplements, biocides, medical devices, medical aids, and cosmetics.

It evaluates and approves new products, monitors their quality, and controls production, clinical studies, and circulation.

The EOF also promotes medical and pharmaceutical research and provides objective information to health scientists, competent bodies, and the public about medicinal products and their pharmacoeconomic dimensions.

Link for Regulatory Authority: https://www.eof.gr/web/guest;jsessionid=f80ef058a793e1e67f6a6c3d906f

Local Regulation:

• MDD 93/42/EEC
• Medical Device Regulation (EU) 2017/745

Classification:Class I, lla, llb, III

• Listing or Registration Requirements:
• Establish a European Authorized Representative (E.A.R.);
• Provide all required documents to E.A.R.;
• A.R. proofs all documents and prepares them for submission;
• A.R. submits required documentation to EOF;
• A.R. provides proof of submission;
• Products may circulate in the Greek market, provided acceptance by the authorities.

Documents Required:

• Name and code of the medical device, its classification, its nomenclature, name of the Manufacturer or its authorized representative or importer
• CE Conformity Certificates
• EC Declaration of Conformity (must be in Greek)
• Packaging box (Box, Labelling and instructions for use (must be in Greek)
• Technical file

Registration Timeline:The registration process takes about 4-6 weeks after submission for Class I devices. For the other classes, it depends on the contract with the notified body and the type of device.

License Validity:5 Years

Special Labelling Requirements:IFU and label of medical devices must be available in Greek

Additional Information: In Greece, all medical devices and in vitro diagnostic (IVD) devices require registration with the National Organization for Medicines (EOF) before market entry. While two relevant regulations were adopted in 2017, their transitional periods have ended, meaning the full regulations are now in effect. To legally sell medical or IVD devices in Greece, ensure they comply with these current regulations.

Who should make this communication:

• Manufacturer
• Authorized Representative

When to make this communication: Before placing a medical device into the market.

Market Overview:

The Greek medical device market is anticipated to exhibit a 5.1% annual growth, reaching $1.4 billion by 2027. However, the market faces challenges such as high inflation, substantial hospital debt, and reliance on imports due to underdeveloped domestic production. Moreover, complexities in reimbursement processes, claw backs, and delays in certifications contribute to the sector’s constraints.

Over 80% of high-value medical equipment in Greece is imported since domestic producers lack the manufacturing capability. While U.S. medical devices have opportunities in Greece, competition, especially from EU firms, remains significant. Germany, Netherlands, and Belgium are the primary sources of medical device imports, with China being the leading non-EU supplier. The U.S. stands as the eighth-largest provider, with major firms like Johnson & Johnson, Medtronic, and Boston Scientific actively participating in the market.

Medical devices necessitate approval from the European Commission for marketing in Greece. Additionally, the National Organization for Healthcare Provision (EOPYY) maintains its approval register for medical devices. To navigate both EU and local requirements, collaboration with local distributors is encouraged for firms entering the Greek market.

How OMC Medical can assist you with the process

• Act as your Authorized representative

Why Choose Us

• Working towards client satisfaction
• Cost effective solutions
• Project completion before deadline
• Quality Regulatory affairs solutions

Contact us for free consultation: [email protected]