The article briefly overviews the European regulatory framework for clinical investigations.
Table of content
The Medical Device Coordination Group (MDCG), a voluntary association of regulating authorities collaborating to improve the legislation applicable to medical devices further, has published a questions-and-answers document dedicated to clinical investigations.
The document provides a brief overview of the applicable regulatory requirements, answers industry representatives’ most essential questions in this respect, and provides additional clarification and recommendations to be considered.
The document could be subject to changes, should such changes be reasonably necessary to reflect corresponding amendments to the underlying legislation.
Introduction
The present document serves as a guide for sponsors involved in clinical investigations of devices within the Regulation (EU) 2017/745 (MDR) framework.
It aims to clarify the terminology and procedures outlined in the MDR, specifically focusing on “devices” as defined by the regulation.
This includes medical devices, accessories, and certain products listed in the MDR Annex XVI.
The document distinguishes between “clinical investigations”, defined as systematic studies assessing the safety or performance of a device, and broader “clinical studies” encompassing a more comprehensive range of medical research.
The general questions addressed in the guidance include, inter alia, the ones described below.
Differences and Improvements under MDR
The MDR above, initially intended to replace Directives 93/42/EEC and 90/385/EEC, introduces significant changes to the existing legal framework.
Unlike a Directive, which sets goals for EU countries to achieve through national laws, a Regulation such as MDR is a binding legislative act that uniformly applies across the EU.
This uniformity ensures consistent rules and procedures, leading to greater predictability and a more conducive environment for clinical investigations.
The MDR provides detailed guidelines on good clinical practice and enhances patient safety standards across member states. Despite this harmonization, sponsors must still adhere to specific national provisions.
Additional Relevant Legislation
It is essential to mention that while the MDR is comprehensive, it is not the sole legislative framework governing clinical investigations of devices. National laws may impose additional requirements, especially for ethics committee reviews and investigator qualifications. Other EU legislations, such as EU Regulation 536/2014 (CTR) and EU Regulation 2017/746 (IVDR), may also be relevant, especially when the study involves products other than medical devices.
Definition of Clinical Investigation
MDR defines a clinical investigation as a systematic study involving human subjects to assess a device’s safety or performance.
This definition is crucial for understanding the scope of MDR applicability.
Scope of Clinical Investigations under MDR
Not all studies involving devices are clinical investigations as per the definition included in the MDR.
The document also emphasizes that studies that use devices that are not intended to assess their safety or performance, such as certain medicinal product trials, fall outside this definition.
However, these devices must still comply with MDR regulations for market placement and use.
Coverage of Clinical Investigations under MDR
The MDR outlines clinical investigation requirements to gather evidence for device conformity.
It also sets basic standards for other types of investigations. Investigations for conformity assessment are regulated under specific articles of the MDR, with distinct purposes such as verifying performance or identifying side effects.
Other investigations not falling under these categories are subject to different requirements and potential additional national regulations.
Differentiating Performance, Clinical Performance, and Clinical Benefit
MDR distinguishes between a device’s performance (its ability to achieve its intended purpose), clinical performance (the actual achievement of this purpose in a clinical setting), and clinical benefit (the positive impact of the device on health outcomes). Understanding these distinctions is critical for accurately assessing and reporting in clinical investigations.
The MDCG guidance includes expanded discussions on several critical areas:
- Ethics and Compliance: The importance of adhering to ethical guidelines and compliance with EU and national legislations.
- Role of Sponsors: Detailed responsibilities of sponsors in conducting and overseeing clinical investigations, including the need for continual updates and ensuring accessibility of documentation to relevant authorities.
- Impact on Patient Safety and Public Health: How MDR regulations enhance patient safety and potentially impact public health outcomes.
- Transparency and Collaboration: The emphasis on transparency in the conduct of clinical investigations and the importance of collaboration among EU Member States.
- National vs EU Regulations: The interplay between EU-wide regulations and national laws, highlighting scenarios where national laws might impose additional requirements.
- Clinical Investigations vs Clinical Trials: Elaboration on the distinction between clinical investigations under MDR and clinical trials of medicines, including the implications for regulatory compliance and ethical considerations.
Conclusion
The document provides an in-depth analysis of MDR’s impact on clinical investigations of devices, highlighting the changes from previous directives, the nuances in definitions and scopes, and the interplay between EU-wide and national regulations.
It details the roles and responsibilities of sponsors and the broader implications for patient safety and public health.
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