GREECE Law and Practice Contributed by: Angela Livgieri and Danai Panopoulou, ALG Manousakis Law Firm
In order to conduct a clinical trial in Greece, prior approval from EOF is required following an application submitted via the Clinical Trials Information System (‘‘CTIS’’), referred to in Article 80 of CTR (art. 3.1 of Ministerial Decision No G5α/59676/2016). The application, the clinical trial protocol, the infor- mation material addressed to patients, the informed consent form, the labelling, the patient cards, and the insurance contract must be submitted in Greek. The rest of the file documentation may be submitted in English. For clarity, non-interventional studies fall outside the scope of CTR and are governed in Greece by Joint Ministerial Decision D3 (α) 52922/2025, which sets out the procedural requirements for approval, contract execution and conduct of such studies. Medical Devices The legal framework applicable to clinical investiga- tions (or performance studies, in the case of in vitro diagnostic medical devices) is set out in Section VI of the MDR and, as the case may be, in Section VI of the IVDR. In Greece, the MDR and the IVDR are directly applicable in conjunction with the Joint Ministerial Decision DY8d/130648/2009 (Article 15 of the said Decision specified the clinical-related rules). Joint Ministerial Decision D3 (α) 52922/2025 sets out the rules for the clinical trial procedure for medical devices in line with articles 62-82 of MDR and 58-77 of IVDR, while it provides for a mandatory agreement template to be used as part of the clinical trial applica- tion (see more details on the procedure in 7. Import and Export of Pharmaceuticals and Medical Devices). 2.2 Securing Authorisation to Undertake a Clinical Trial Pharmaceuticals Clinical trials are subject to scientific and ethical eval- uation and are approved in accordance with Article 8 of the CTR. The EOF conducts a scientific evalua- tion of the clinical trial. If the EOF has been granted the status of “reporting” member state, it notifies the sponsor and the other concerned member states via the CTIS within six days of submitting the application file (Article 5 of the CTR).
Ethical evaluation is carried out by the National Eth- ics Committee, which drafts an assessment report in accordance with the procedure set out in Article 7 of the CTR. A positive scientific (by EOF) and ethical (by National Ethics Committee) assessment of the clinical trial is required for its approval (Article 3.1b of Ministerial Decision No G5α/59676/2016). Medical Devices According to articles 62 of the MDR and 58 of the IVDR, both clinical investigations and performance studies are subject to an authorisation by the Member State in which the clinical investigation or the perfor- mance study is to be conducted, following a scientific and ethical review, the latter being performed by an ethics committee, according to the national law. As per above, competent authorities are the EOF and the National Ethics Committee. The Joint Ministerial Decision D3 (α) 52922/2025 (Arti- cles 11et seq.) establishes the national legal and pro- cedural framework for the conduct of clinical investi- gations with medical devices in Greece, in alignment with MDR and IVDR. For investigations outside the device’s intended purpose, the principal investigator must obtain both National Ethics Committee approval and EOF authorisation; for investigations within the intended purpose, a simplified pathway requires National Ethics Committee approval and submis- sion to the institution’s Scientific Committee, which must respond within thirty working days or approval is legally presumed. 2.3 Public Availability of the Conduct of a Clinical Trial Greece has no national database for clinical trials of medicines or medical devices. Clinical trials are reg- istered and managed exclusively through the central European CTIS. The CTIS serves as both the single EU submission portal and a publicly accessible data- base of clinical trials conducted in the EU. CTIS. Information on authorised clinical trials is published in CTIS in accordance with the transparency rules and deferral mechanisms laid down in CTR, subject to the
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