Best Drugs & Medical Devices Lawyers in Kos

1. About Drugs & Medical Devices Law in Kos, Greece

Kos is part of Greece, so national health and safety laws apply to medicines and medical devices sold or used on the island. The Greek authorities regulate marketing authorization, distribution, advertising, and post-market safety through the Ministry of Health and the National Organization for Medicines (EOF). In addition, Europe-wide rules govern how medical devices and medicines can be placed on the market, and Greece implements these rules through national law and agency guidelines. For residents of Kos, enforcement typically follows the same procedures as mainland Greece, with local police and health inspectors coordinating with national bodies.

Understanding the local context matters. Pharmacists, clinics, and device suppliers in Kos must comply with both EU regulations and national Greek rules. This means proper labeling, CE marking where required, and timely reporting of adverse events or recalls. A local attorney who understands both national and EU frameworks can help navigate licenses, inspections, and potential penalties.

Recent changes in EU policy have heightened focus on transparency and safety for medicines and devices. Greek authorities have increasingly prioritized post-market surveillance, inspections of pharmacies and clinics, and rapid response to recalls or safety alerts. This has direct implications for operations in Kos, where small clinics and pharmacies may interface with national regulators more frequently than rural areas elsewhere.

EU MDR and IVDR reforms focus on device safety, CE conformity, and enhanced post-market surveillance across the EU, including Greece.

Source: EUR-Lex - Medical Devices Regulation (EU) 2017/745

EU IVDR strengthens controls for in vitro diagnostic devices and introduces stricter conformity assessment and vigilance requirements in the EU, including Greece.

Source: EUR-Lex - In Vitro Diagnostic Regulation (EU) 2017/746

Greek health policy and regulatory implementation are coordinated through the Greek government portal and health authorities to align with EU regulations.

Source: gov.gr

2. Why You May Need a Lawyer

• Scenario 1 - Kos pharmacy charged with selling unregistered medicines: A local pharmacist in Kos discovers a supplier shipped medicines without proper licensing. A lawyer can review licenses, assist with defense, and help negotiate settlements with regulators.
• Scenario 2 - Importing a medical device into Kos without proper CE marking: A Kos importer tries to clear a device that lacks the required CE certificate or EU conformity assessment. An attorney can advise on compliance steps and represent you in regulatory investigations.
• Scenario 3 - Adverse event or recall involving a device used in a Kos clinic: A patient reports an injury from a device used in a Kos clinic, triggering a safety alert. A lawyer helps coordinate pharmacovigilance communication and potential legal claims.
• Scenario 4 - A local startup in Kos seeking market authorization for a drug or device: A Kos-based company needs regulatory strategy, documentation, and liaison with EOF for approvals and post-approval obligations.
• Scenario 5 - Compliance review after a hospital fines or inspectors visit: A Kos hospital faces compliance issues after an inspection. Legal counsel can organize remediation plans and manage penalties or settlements.
• Scenario 6 - Advertising or promotion disputes for a pharmaceutical product in Kos: Unapproved advertising or misleading claims can trigger penalties. A lawyer can assess marketing materials and respond to regulators.

3. Local Laws Overview

In Kos, as in all of Greece, two key regulatory strands govern drugs and medical devices. First, EU level rules apply directly to market access and safety obligations for devices and medicines. Second, Greece transposes and implements these rules through national regulations, guidelines, and the work of the National Organization for Medicines (EOF).

Major regulatory frameworks include the following named laws and regulations:

• EU Medical Devices Regulation (EU) 2017/745 - governs the marketing, conformity assessment, and post-market surveillance of medical devices across the EU, including Greece and Kos. It replaced the previous Directives and emphasizes CE marking and vigilance.
• EU In Vitro Diagnostic Regulation (EU) 2017/746 - governs in vitro diagnostic devices, with stronger clinical performance documentation and oversight across member states like Greece.
• Directive 2001/83/EC on medicinal products for human use - forms the basis for medicines regulation in the EU and, via Greek national law, remains a reference point for licensing, advertising, and pharmacovigilance in Greece, including Kos. Greece has implemented updates to align with EU harmonization efforts.

Recent trends in Greece point to enhanced enforcement and tighter post-market obligations for both medicines and devices. Authorities in Kos increasingly conduct routine inspections of pharmacies and clinics, with greater emphasis on traceability, labeling, and adverse event reporting. This is part of a broader EU-wide push to standardize compliance and improve patient safety.

For residents and businesses in Kos, understanding these frameworks is essential before launching product distribution, importing devices, or advertising medicines. A local attorney can help map the applicable regulatory path and coordinate with EOF and health authorities as needed.

4. Frequently Asked Questions

What authority regulates medicines and devices in Kos, Greece?

Regulation is coordinated by the Greek Ministry of Health and the National Organization for Medicines, with EU laws also applying. Local authorities in Kos enforce compliance and coordinate with national regulators. A lawyer can help interpret the applicable rules for your situation.

How do I register a new medical device in Greece from Kos?

You must prepare conformity documentation and obtain CE marking under EU MDR, then submit the dossier to the EOF or relevant Greek authority. An attorney can guide documentation preparation and liaise with regulators to avoid delays.

When did the EU Medical Devices Regulation take effect in Kos?

EU MDR took effect across the EU on 26 May 2021, and Greece implemented the regulation through national guidance and EOF oversight. This affects how devices are marketed in Kos.

Where can I report a drug adverse event in Kos?

Adverse events can be reported to the EOF and the national pharmacovigilance system. Local health authorities in Kos may also receive reports and coordinate investigations.

Why might a Kos pharmacy face penalties for unregistered medicines?

Unregistered medicines undermine safety and market control, triggering penalties under Greek health regulations. The penalties depend on the severity and intent, and a lawyer can help negotiate outcomes.

Can I challenge a device recall decision in Kos?

Yes, you can challenge recalls through the appropriate regulatory or judicial channels. A lawyer can file petitions, demand hearings, and coordinate evidence submission.

Should a Kos clinic hire a local lawyer for drug related matters?

Yes. A local attorney familiar with Kos regulatory practices can liaise with EOF, prepare filings, and manage communications with authorities efficiently.

Do I need a Greek tax ID to import a medical device into Kos?

Importing medical devices typically requires registration with Greek tax authorities and compliance with customs procedures. A lawyer can guide you through the registration and import steps.

Is CE marking required for medical devices sold in Kos?

Yes. CE marking is generally required to market devices in the EU, including Greece and Kos, under the MDR. Non-compliant devices may be subject to penalties and recalls.

How long does a clinical trial approval take in Greece?

The timeline varies by trial type and documentation. In Greece, ethics approval and regulatory review are needed, and a local attorney can help coordinate the process and reduce delays.

What is the difference between a drug license and a device CE mark in Kos?

A drug license authorizes marketing a pharmaceutical product, while a device CE mark confirms conformity with MDR for devices. They are separate streams with distinct requirements and regulators.

How much can penalties be for advertising violations in Greece?

Penalties depend on the nature and extent of the violation. Enforcement is done by Greek authorities, and counsel can help assess risk and negotiate alternatives or settlements.

5. Additional Resources

• Gov.gr - Official Greek government portal for public services, including health and regulatory information applicable to medicines and devices. https://www.gov.gr
• World Health Organization (Greece office) - Official international health organization with country-level health information and guidance relevant to medicines safety and public health. https://www.who.int/countries/greece
• European Union: Medical Devices Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) resources - EU regulatory framework reference for device and diagnostic regulation applicable in Greece and Kos. MDR 2017/745 on EUR-Lex • IVDR 2017/746 on EUR-Lex

6. Next Steps

1. Clarify your objective and the regulatory path by listing all medicines or devices involved and the intended market in Kos.
2. Gather all relevant documents, including product specifications, labeling, and any prior approvals or registrations.
3. Consult a Drugs & Medical Devices lawyer with experience in Greek and EU regulations specific to Kos and your product type.
4. Schedule a formal intake to review compliance status, risks, and a strategy for engagement with EOF or other regulators.
5. Develop a plan with timelines for licensing, conformity assessments, or pharmacovigilance activities as needed.
6. Prepare a cost estimate and fee structure for regulatory work, filings, and potential hearings or appeals.
7. Once engaged, implement the plan with regular check-ins and documentation updates to maintain compliance in Kos.