The article provides a general overview of the approach to be followed when creating a clinical investigation plan for medical devices.
Table of content
The Medical Device Coordination Group (MDGC), an advisory body comprised of the representatives of the EU Member States focused on the general improvement of the regulatory framework in the sphere of medical devices, has published a guidance document dedicated to the content of the clinical investigation plan for clinical investigations of medical devices.
The document provides an overview of the applicable regulatory requirements, 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, including clinical investigations, to ensure compliance with it.
At the same time, MDCG reserves the right to make changes to the guidance and recommendations provided therein, should such changes be reasonably necessary to reflect corresponding amendments to the underlying legislation or accommodate the recent technology developments and arising needs.
In particular, the document describes in detail the content of a Clinical Investigation Plan (CIP) to be prepared by the responsible parties, highlighting the key aspects to be considered.
Introduction
Although not an official European Commission document, this document offers essential insights into the expectations and regulatory requirements outlined by the MDR (Medical Device Regulation EU 2017/745).
Sponsors are expected to submit comprehensive applications that are supported by the documentation specified in the MDR, ensuring their investigation plans reflect the latest scientific knowledge and are capable of validating the safety and effectiveness of their devices.
This guidance details the expected content in a Clinical Investigation Plan to facilitate the conduct of clinical investigations in alignment with legal standards and best practices.
Purpose of the CIP
According to the guidance, the Clinical Investigation Plan is vitally important for successfully executing a clinical investigation, outlining the rationale, objectives, and methodologies. It acts as a manual for investigators, ensuring consistent application across sites and over time.
The plan safeguards participants and third parties, ensuring any risks are justified by the expected clinical benefits.
Additionally, it facilitates competent authority and ethics committee assessments by demonstrating that the investigation’s design adequately minimizes risks and that the data collected will be robust and reliable.
Regulatory Framework and Compliance
As further explained in the document, the relevant legal framework comprises the MDR and the applicable ISO standard (ISO14155:2020), addressing the matters related to good clinical practice.
However, it is explicitly stated that even though provisions of the standard mentioned above are essential and should be considered by the parties involved, the relevant provisions of the MDR should prevail.
The document encourages sponsors to harmonize their CIPs with the requirements outlined in the above mentioned regulations and standards to ensure the accuracy and reliability of the investigation results.
Developing the CIP
According to the guidance, sponsors should tailor their CIPs based on the investigational medical device’s specific nature and development stage. This involves addressing or justifying any deviations from the legal requirements detailed in the MDR.
The document is structured to facilitate cross-referencing with the MDR, ensuring comprehensive coverage of all necessary elements without serving as a direct template.
The flexibility in structuring the CIP is particularly relevant for combined studies of medical devices and pharmaceutical products, where integrating multiple regulatory requirements is essential.
Best Practices and Considerations
The guidance also outlines the best practices and considerations for sponsors developing their CIP. In particular, the document emphasizes the importance of the detailed planning and documentation required to ensure clinical investigations’ ethical and scientific support.
This includes the rigorous design of study methodologies, monitoring plans, record-keeping, and data analysis methods.
The goal is to ensure clinical investigations comply with regulatory requirements and contribute valuable, reliable data to medical science.
Conclusion
In summary, the present document issued by the MDCG provides an in-depth overview of the relevant regulatory requirements on clinical investigations to be conducted for the products intended to be marketed and used in the EU.
The document outlines the key points to be considered by the parties involved to ensure compliance with the respective legal framework.
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