Medical Device Registration in Greece - An Overview
Entering the Greece market offers tremendous opportunities for medical device companies, but it is not without challenges. A professional partner with experience and expertise in Greece is a cornerstone for your success, which could be the difference between approval and failure. Here is the ultimate guide for Medical Device Registration in Greece with more details on device classification and approval process for Greece. The Greek healthcare market, inclusive of medical devices, diagnostics, supplies and pharmaceuticals, is extensively dependent on imports, with local production mostly active in generics and the so-called “branded generics”.
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Making Greece a gateway to SE Europe could offer the country economy of scale advantages. However, the financial crisis, combined with uneasiness brought by the current refugee situation, has resulted in instability. The government is finalizing the merger of certain hospital units and attempting a twenty-four-hour operation standard within all public hospitals, with a greater level of transparency in hospital financial transactions and hospital procurement.
Healthcare expenditures currently amount to 5.4% of Greece’s diminishing Gross Domestic Product (GDP). This expenditure has traditionally comprised of approximately 60% government-provided care and 40% private care. Preference for receiving private healthcare has traditionally been higher in Greece because nearly any procedure can be performed and wait times are much lower in private hospitals.
In addition, if a procedure requires an overnight stay, the largely crowded and rundown appearance of public hospitals is something people wish to avoid when they have the option. Despite that preference, fewer Greek citizens can afford to pay for private care out of pocket or to continue paying for private health insurance policies.
Registration Process for Medical Devices in Greece
- Determine device classification based on risk.
- Compile comprehensive technical documentation.
- Appoint an authorized representative in Greece.
- Submit a registration application to the Greek National Organization for Medicines (EOF).
- Await review and evaluation by the EOF.
- Obtain the registration certificate upon approval.
- Comply with post-market surveillance and vigilance requirements.
Please note that these points provide a high-level overview, and it’s important to delve into the specific regulations and requirements applicable to your medical device in Greece.
Documents Required
- CE Certificate
- Technical File
- Declaration of Conformity
- Clinical Evaluation Report (CER)
- Risk Management File
- QMS certificate
- Labelling
Some Post-market Requirements for Medical Devices in Greece
- Post-Market Surveillance (PMS)
- Adverse Event Reporting
- Field Safety Corrective Actions (FSCA)
- Labeling and Instructions for Use
- Quality Management System (QMS)
- Vigilance Reporting
- Market Surveillance Inspections
Market Surveillance and Vigilance
In both the EU and the US, all medical devices are subject to further monitoring in order to assess their safety and performance efficiency. In the US one of the most important amendments in this regard is the Safe Medical Device Act that came into effect in 1990.
In the European Union, up until 2017, this issue was regulated by the Medical Devices Directives (MDD). However, these directives were recently replaced by the EU MDR and IVDR regulations.
The Safe Medical Device Act in the United States brought lots of tension to the adverse event reporting process. Medical devices directives and the EU MDR/IVDR regulations have also created a uniformed regulatory situation in the EU. However, there are bigger variances in applicable regulations in the EU from country-to-country than in the US from state-to-state.
One example is that essentially all countries within the EU also have their own databases for monitoring medical devices and adverse reporting (EOF database) apart from Eudamed. Many countries also require extra information to provide, for example, Germany uses their own DIMDI system registrations processing.
Medical devices in Greece are regulated by The National Organization for Medicines (EOF), a public entity of the Ministry of Health. Greece, as a member of the European Union, classifies medical devices according to their risk into four classes: I, IIb, IIb, and III.
Class I medical devices are associated with the lowest risk, while Class III devices are associated with the highest risk. In order to market their medical devices throughout the European Union, manufacturers must make sure that all the products they intend to distribute in Greece are CE-marked. CE marking serves as a proof of conformity within the current European Union regulations.
A CE mark allows for the device to be marketed within all EU member states. Once a medical device is granted with CE marking, it can be distributed in any of the European Union countries. It doesn’t have to be registered in a country where it is going to be marketed – registering a given medical device in Greece allows for it to be distributed in Germany, France, United Kingdom or any other EU member state.
The time frame of the registration process can vary depending on the type and Class of device. The process is usually the quickest for Class I devices. It is also important to note that all registrations in the EU, and thus in Greece, are valid for 5 years. Manufacturers are also obligated to have a Quality Management System (QMS). The most popular choice in this regard is ISO 13485 certification, which is valid for three years.
Foreign manufacturers that are not registered in the EU must appoint an Authorized Representative (AR), which will assist with the registration process and post-market surveillance activities.
Operon Strategist enjoys a high reputation and widespread acclaim for successful medical device registration experience in globally. We provide high quality, high efficiency and reliable service of medical device regulatory consulting and registration for clients from over various countries. As an expert in regulatory affairs in the medical device industry, we possess enormous successful registration experience for all types of medical devices or IVD. Operon Strategist is the absolute leading forerunner for medical device approval in Greece and gets your products into Greece market faster.
