The new article clarifies the aspects related to the pre-clinical evaluation the device should undergo before it will be allowed for use in patients.
Table of content
The Medical Device Coordination Group (MDCG), an advisory body focused on further improvement of the medical device regulatory framework, has published a guidance document dedicated to the content of the Investigator’s Brochure for clinical investigations of medical devices.
The document provides an overview of the regulatory requirements set forth under the existing legal framework, as well as additional clarifications and recommendations to be taken into consideration by medical device manufacturers, study sponsors, and other parties involved in operations with medical devices intended to be marketed and used in the EU.
The scope of the guidance covers, inter alia, the aspects related to the pre-clinical evaluation of medical devices.
Introduction to Pre-clinical Evaluation
According to the guidance, in the context of medical device regulation, pre-clinical evaluation stands as a crucial step in ensuring the safety and efficacy of investigational devices before they are introduced to human subjects. As prescribed by Annex XV of the Medical Device Regulation (MDR), this evaluation entails a comprehensive examination based on a range of pre-clinical testing methodologies and experimental data.
The revenant section of the guidance delineates the general and specific recommendations pertaining to pre-clinical evaluation, emphasizing the need for adherence to safety standards, meticulous testing, and transparent reporting.
General and Specific Recommendations
The MDR stipulates that investigational devices must adhere to the applicable General Safety and Performance Requirements (GSPR) outlined in Annex I. This necessitates thorough pre-clinical evaluation to safeguard the health and safety of subjects participating in clinical investigations.
The evaluation encompasses technical, biological, and occupational safety considerations, in line with prevailing standards and the latest technological advancements. The MDCG explicitly states that pre-clinical tests should be finalized before the submission of a clinical investigation application.
The extent of testing should sufficiently support the intended use of the device in clinical settings, with deviations from acceptance criteria requiring justification.
Documentation and Reporting
According to the guidance, the IB serves as a repository of pre-clinical testing data and evaluation outcomes, providing a comprehensive summary justifying the device’s suitability for human subjects.
The MDCG further encourages the use of standardized reporting formats, including tabular summaries to facilitate clarity and accessibility of information, ensuring that both experts and non-experts can comprehend the findings. Incorporating in-design calculations can also support the structural integrity and mechanical robustness of the device, underpinning its reliability and performance.
Bench Testing
As explained by the MDCG, performance testing is intended to assess whether the device achieves its intended purpose as defined by the manufacturer, focusing on clinical performance requirements and corresponding specifications, including in vitro, ex vivo, or animal testing as deemed relevant. Ensuring device reliability involves evaluating its ability to function adequately over a specified period, encompassing durability assessments, stability testing, and simulations to mitigate potential failures.
Furthermore, interoperability and compatibility testing are vitally important for devices intended to operate in conjunction with others, necessitating verification of seamless integration, data exchange, and functional compatibility. Usability assessments should focus on optimizing user interaction, effectiveness, and satisfaction within the intended use environment, thereby augmenting device safety and performance.
Animal Tests
The MDCG acknowledges that in vivo animal tests could still provide crucial insights into device safety and efficacy, necessitating study designs, transparent reporting, and adherence to ethical guidelines. Comprehensive summaries of animal tests, including study designs, results, and evaluations, facilitate regulatory scrutiny and enhance transparency in reporting.
Conclusion
In summary, the present MDCG guidance emphasizes the importance of pre-clinical evaluation for ensuring compliance with the relevant regulatory requirements in terms of the safety and effectiveness of medical devices prior to the commencement of clinical investigations. The document explains the role of pre-clinical evaluation in the context of risk assessment and mitigation.
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