Navigating the complex landscape, often experienced as jungle, of regulatory requirements for clinical investigations with medical devices can feel like venturing into a dense jungle. With countless legal provisions, ethical guidelines, and international standards to consider, ensuring compliance can be a daunting challenge. Yet, understanding these rules is crucial—not just for meeting legal obligations but for upholding the safety and dignity of study participants and ensuring data integrity.
This blog post provides an overview where to find regulatory and ethical requirements that are critical for planning and conducting clinical investigations in Austria. MDR requirements, national regulations, and international standards, we summarize the most important sources necessary for legally compliant and ethically sound clinical investigations.
The Legal Framework
Medical Device Regulation (EU) 2017/745 (MDR)
The MDR outlines detailed requirements in Articles 62 – 80 and Annex XV. These include the roles of sponsors, planning, approval and submission, execution, documentation, and reporting. This includes all parties involved, such as sponsors, clinical study sites, and investigators.
Link: https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:32017R0745&from=DE
Austrian Medical Device Act 2021 (MPG 2021)
The MPG 2021 regulates specific national provisions and specifies requirements in Section 3 (§13 – 36). This section addresses non-interventional studies, the establishment and organization of ethics committees, and the involvement of the Federal Office for Safety in Health Care (BASG). It also covers data protection, quality control, quality management, insurance coverage and additional responsibilities of sponsors.
The Ethical Principles
Declaration of Helsinki – Ethical Principles for Medical Research Involving Human Subjects
The Declaration of Helsinki establishes ethical principles for medical research involving human subjects. It places the protection of human dignity, safety, and well-being of study participants at the forefront. It serves as a global foundation for ethically responsible research, requiring transparent risk assessment, participant consent, and meticulous documentation.
Link: https://www.wma.net/policies-post/wma-declaration-of-helsinki/
Applicable Standard
ISO 14155:2020 Clinical Investigation of Medical Devices for Human Subjects — Good Clinical Practice
ISO 14155 defines standards for the clinical investigation of medical devices and ensures compliance with Good Clinical Practice (GCP). Aim is to protect participants and to guarantee reliable results. It helps manufacturers conduct clinical investigations according to internationally recognized guidelines. This paves the way for legally compliant and ethical research outcomes. Although the standard is not listed as a harmonised standard, working in accordance with this standard is highly recommended.
European Committee for Standardization. ISO 14155:2020 Clinical investigation of medical devices for human subjects — Good clinical practice. Brussels: CEN-CENELEC Management Centre, 2020
National Guidance Documents for Austria (available in German)
Guideline for the submission of clinical investigations (March 2022)
This guideline of the Austrian Federal Office for Safety in Healthcare provides information on the application for approval or notification of a clinical investigation according to the MDR.
Guideline for the classification of change requests (March 2022)
This guideline offers guidance for classification and reporting of amendments during a clinical investigation.
Further Guidance Documents
In addition to the laws and standards listed above, the European Commission provides a series of guidance documents. While these documents are not legally binding, their aim is to support stakeholders in implementing legal and ethical requirements and to promote the uniform application of MDR provisions. Below is a list of the currently issued guidance documents for clinical investigations:
MDCG 2024-15: Guidance on the publication of the clinical investigation reports and their summaries in the absence of EUDAMED
(November 2024)
The latest MDCG document offers guidance on procedure to be followed by the clinical investigation sponsor under the MDR for submitting the clinical investigation report and its summary to national competent authorities, in the absence of the European database on medical devices (EUDAMED) Clinical Investigation module.
MDCG 2024-5 Guidance on the Investigator’s Brochure content and MDCG 2024-5 Appendix A (April 2024)
This document provides the recommended content and format for the Investigator’s Brochure required for clinical investigations of medical devices within the EU.
MDCG 2024-3 Guidance on content of the Clinical Investigation Plan for clinical investigations of medical devices and MDCG 2024-3 Appendix A Clinical Investigation Plan Synopsis Template (March 2024)
This document outlines the recommended content and format for the Clinical Investigation Plan (CIP) required for clinical investigations of medical devices within the EU.
MDCG 2023-7 Guidance on exemptions from the requirement to perform clinical investigations pursuant to Article 61(4)-(6) MDR and on sufficient levels of access’ to data needed to justify claims of equivalence (December 2023)
This document offers guidance on applying the exemptions to the requirement for conducting clinical investigations for medical devices, as outlined in MDR Article 61(4)-(6). Additionally, it addresses the criteria for determining “sufficient levels of access” to data necessary for equivalence claims.
MDCG 2021-6 – rev. Regulation (EU) 2017/745 – Questions & Answers regarding clinical investigation (December 2023)
This guidance covers general questions, application content, safety reporting, and other aspects of clinical investigations covered by the MDR.
2023/C 163/06 Commission Guidance on the content and structure of the summary of the clinical investigation report (May 2023)
This document offers guidance and intends to ensure that the summary of the clinical investigation report presents information about the design, conduct, analysis and results of the clinical investigation in clear, user-friendly terms and a format easily understandable to the intended user of the medical device.
MDCG 2020-10/1: Guidance on safety reporting in clinical investigations und MDCG 2020-10/2: Appendix: Clinical investigation summary safety report form (October 2022)
This guidance covers all safety reporting obligations in line with the MDR Article 80(2) for clinical investigations with non-CE marked devices and MDR Article 80(5) and (6) for post-market clinical follow up (PMCF) investigations with CE-marked devices used within the CE-mark. It also provides information to support the procedures in the absence of the EUDAMED Clinical Investigation module
MDCG 2021-28: Substantial modification of clinical investigation under Medical Device Regulation (December 2021)
This guidance provides information for the responsibility of the sponsor concerning the notification of the Member States in case modifications to a clinical investigation are planned.
MDCG 2021-20 Instructions for generating CIV-ID for MDR Clinical Investigations (July 2021)
This guidance provides general information to sponsor on how to generate a CIV-ID for a clinical investigation, and also provides guidance on how to obtain this ID before EUDAMED is fully functional.
MDCG 2021-8: Clinical investigation application/notification documents (May 2021)
This guidance provides information and a series of clinical investigation application/notification documents to support the procedures in the absence of the EUDAMED Clinical Investigation module.
All MDCG Guidance Documents are available on the official website of the European Commission
Conclusion: Jungle? Yes – but with a map that’s slowly becoming clearer
The regulatory landscape for clinical investigations in the EU is undoubtedly complex, with a wide range of requirements to ensure both compliance and the protection of study participants. However, alongside these demands, there is an abundance of guidance available to help sponsors and investigators navigate these challenges effectively.
The MDCG has published a variety of detailed guidance documents, offering clarity on key requirements for clinical investigations under the MDR. Furthermore, new guidance continues to emerge, providing even greater support for staying compliant and ensuring ethically and scientifically sound research.
By leveraging these resources and staying informed about updates, you can successfully navigate the regulatory “jungle.” At VASCage, we are here to support you every step of the way, ensuring compliance and enabling you to focus on conducting high-quality clinical investigations that prioritize patient safety and data integrity
Need assistance with planning and executing your clinical study or investigation?
Our team guides you through all steps of your clinical study—from selecting the optimal study design to compliant implementation. This way, you can save time and costs without compromising on quality. Use clinical studies as a strategic tool to advance your product development effectively and establish a strong foundation for a successful market launch.
We are here to help and support you in developing an optimal clinical strategy for safe, effective, and market-ready products. Our expert team ensures smooth planning and execution of clinical studies that meet both, regulatory requirements and your project goals.
Explore our website to learn more about how we can support you as a medical device manufacturer. Feel free to contact us at studien@vascage.at.
