The new article outlines the scope of general information to be covered by a clinical investigation plan a party responsible for the inquiry should prepare.
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 considered 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.
According to the guidance, the CIP outlines the critical aspects of clinical investigations.
It includes, among other things, a comprehensive summary, ensuring all pertinent information is readily available within the document itself.
In instances where additional documents supplement the CIP, they are to be summarized and referenced, forming an integral part of the initial submission package for the clinical investigation application.
Overview
First of all, a clinical investigation plan should contain a detailed introductory part addressing, among other things, the following matters and elements:
- The title of the clinical investigation.
- The CIP reference number(s).
- The current version and date of the CIP.
- A detailed revision history, if applicable.
- A list of abbreviations and acronyms used.
- A comprehensive summary of the clinical investigation, adhering to the template provided in Annex A for guidance.
As the guidance explains, such an introduction offers a clear picture of the investigation’s framework and ensures consistency throughout the document.
The abovementioned summary should be provided in one of the official languages of the European Union.
Key Contacts and Roles
The CIP should also contain all the necessary information about the key persons involved in the investigation process, as well as the relevant entities, including:Sponsor and legal representative details.
- Principal and coordinating investigators, along with their qualifications and responsibilities.
- Investigational sites and other involved organizations such as laboratories or clinical research organizations.
- Manufacturer of the investigational device.
In the case of complex studies, responsible parties are expected to provide comprehensive information about the relevant roles, paying special attention to responsibilities across different investigation phases.
Administrative Details
According to the guidance, the administrative part of a clinical investigation plan should cover, among other things, the following aspects:
- Financial background of the investigation.
- Agreements between the sponsor and the site(s), and if applicable, between the sponsor and the device manufacturer.
- Provisions for the investigational device and proprietary information.
The above details are needed to ensure transparency and compliance with the fundamental ethical principles and considerations.
Investigational Device Identification and Description
The document further outlines the scope of information to be provided concerning the device subject to investigation.
This section should contain a precise description of the investigational device, including:
- Its intended purpose, target populations, and indications;
- Clear distinctions between the device’s clinical investigation purpose and its intended market purpose;
- A detailed description of the device’s technical and functional features, specifically those under investigation.
According to the document, it is also necessary to provide information about the medical device manufacturer responsible for the product and certain additional aspects associated with it. This information includes:
- Manufacturer details;
- Model or type identification, including software versions and accessories, to ensure full traceability;
- A list of materials in contact with body tissues or fluids and any incorporated medicinal, human, or animal substances.
Operational details to be included in the submission should cover, among other things, the following aspects:
- Required training and experience for device use based on risk assessment;
- Description of medical or surgical procedures involving the device;
- A comprehensive background literature review provides the context for the investigation.
Conclusion
In summary, the present guidance provides a detailed overview of the information to be included in the clinical investigation plan associated with the medical device undergoing clinical investigation before being placed on the market.
The document emphasizes the key points to be addressed in the plan. Also, it provides additional recommendations to be considered to ensure the completeness of the information provided.
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