Strategic Alignment of National and EU Frameworks:
The New Regulatory Direction in Clinical Research and Medical Devices
Ioanna Michalopoulou, Managing Partner LL.M
Angelos Georgamlis, Trainee Lawyer LL.B
The targeted amendment of Regulations (EU) 745/2017 on medical devices (MDR) and 746/2017 on in vitro diagnostic medical devices (IVDR) by the European Commission is not merely a technical adjustment of the Union’s regulatory framework but is part of a broader strategy emphasizing proportionality, process acceleration, and enhanced predictability for economic operators. The introduction of clear deadlines strengthened oversight of notified bodies, and the establishment of innovative support tools creates a more functional and competitive regulatory environment, without compromising the level of public health protection.
In the same spirit, the Greek regulatory reform on clinical trials and medical devices, through Joint Ministerial Decision (JMD) No. D3(a)/52922/2025/26 (Government Gazette, Series B, No. 230/2026), implements at the national level the principles of acceleration, transparency, and institutional accountability. Parallel submission of files, binding deadlines for signatures, and the standardization of financial management serve as practical instruments to implement EU directives, creating a coherent regulatory environment from certification and evaluation to clinical research. In this way, the national regulation operates not in isolation but complementarily on European developments. The new Joint Ministerial Decision No. D3(a)/52922/2025/26 (Government Gazette, Series B, No. 230/2026) systematically extends the framework to clinical investigations involving medical devices and in vitro diagnostics.
Unlike the previous regime, which was characterized by sequential approvals, multiple institutional stages, and a lack of clear timelines, the new framework introduces parallel administrative processing of files. Submissions are now made simultaneously to the conducting center, the competent financial management authority, and the Hellenic National Organization for Medicines (EOF), significantly reducing the time between regulatory approval and contract activation. This shift from sequential to parallel processing is a critical acceleration factor. New binding timelines specify 5 working days for signature by the center’s legal representative, 8 working days for the ELKE/ELKEA (Special Account for Research Funds) and 2 days for document transmissions.
At the same time, the requirement for prior approval from an Administrative or Scientific Board before contract signing is eliminated. In comparison with the provisions of the previous Joint Ministerial Decision D3(a) 36809 (Government Gazette No. 2015/2019),”, this represents clear de-bureaucratization and a shift from collective advisory filters to administrative responsibility with personal accountability. Furthermore, acceptance of certified electronic signatures, full electronic submission of files, and digital document circulation signal a transition to a modern governance model aligned with European standards.
Special emphasis is also placed on financial transparency. The new framework specifies a clear allocation of costs to the sponsor, standardized retention rates in favor of management authorities, and immediate invoicing by the conducting center. Each study is assigned a unique “Clinical Trial Reference Code”, while all costs, such as hospitalization, examinations, or complications, are borne by the sponsor. The conducting center invoices immediately, with a uniform retention rate of 5% for ELKE/ELKEA and 15% for the center itself. Compared to the previous system, the regulation detaches studies from the regular budget of public healthcare facilities, ensuring financial oversight and transparency.
Equally significant is the establishment of a clear and mandatory disciplinary framework for clinical trials, applying to all parties involved, from investigators and conducting centers to study sponsors. Penalties include administrative sanctions such as temporary suspension from participation in new clinical trials, fines imposed on the center or investigator, and, in severe cases, exclusion from public funding or grants through ELKE/ELKEA. Specifically, in cases of unjustified delays or negligent performance of duties in contract signing and financial management of a clinical trial: (a) the Minister of Health, as disciplinary supervisor, may impose on hospital and Regional Health Authority (RHA) Directors a reprimand or a fine of up to one month’s salary (the previous penalty of dismissal for repeated offenses is removed); and (b) the RHA Director or the Director/Chair of the hospital, as disciplinary supervisor, may impose on members of ELKE/ELKEA or the Scientific Board (where advisory opinion is required) a reprimand or a fine of up to half of their monthly salary. Regarding disciplinary oversight of Directors/Managers of military hospitals, as well as the Chairpersons and members of the ELKE Research Committee, the applicable regulations for each personnel category apply. Disciplinary sanctions may include written reprimands or fines of up to half of the monthly salary.
A cornerstone of the reform is the explicit integration of clinical investigations of medical devices into the same organizational framework, creating a unified and coherent regulatory field. The new framework aligns clinical investigations of medical devices with the same regulatory and organizational structures as pharmaceutical studies, introducing a unified contractual standard between sponsor and conducting center with clear cost allocation, while financial management follows the same rules applicable to pharmaceutical studies. This means that approval procedures, timelines, and documentation requirements for medical device studies are now harmonized with those for pharmaceuticals, instead of being subject to separate or more ambiguous procedures as in the previous regime. Similarly, oversight and institutional accountability are strengthened, as contracts and financial arrangements for medical devices now follow standardized protocols with electronic document circulation. This integration facilitates faster approval and activation of studies while ensuring that research activities for medical devices can be monitored and evaluated according to the same rules applied to pharmaceutical products.
In conclusion, the new national regulatory framework places Greece in full alignment with European regulations for medical devices and clinical trials, simultaneously combining acceleration, predictability, and strict accountability at every stage of the process. Parallel file submission, standardized contracts, and clear allocation of financial responsibilities ensure that studies are conducted without unjustified delays, while the establishment of disciplinary sanctions for investigators, conducting centers, and sponsors enhances compliance with timelines and management duties. Consequently, integrating medical device studies into the same organizational framework as pharmaceutical studies creates a unified and coherent regulatory environment, promoting transparency, responsibility, and reliability in procedures, while facilitating rapid evaluation and activation of research activities, ensuring full monitoring and oversight under the same rules applied to pharmaceutical products. This framework represents a modern, functional, and harmonized model for clinical research, where public health protection, administrative efficiency, and financial management coexist with clarity and security.
