An investigational device is a product that is investigated in a clinical investigation according to the Medical Device Regulation. The term includes products with or without CE marking and also covers a CE-marked product when it is evaluated in a clinical follow-up as part of a study.
Role within the Clinical Investigation
The investigational device is the specific object whose safety or performance is the focus of the clinical investigation. Its identity must be clearly described in the clinical investigation plan, the instructions for use for the study, the risk assessment, and the documentation for the investigational sites. This includes configuration, accessories, software version, and intended use.
Whether a product is already CE-marked does not change the definition. However, it can influence the regulatory pathway of the investigation, for example, if the study investigates an application outside the intended purpose. The submission must therefore not only state the product status but also explain which question remains open in the planned clinical investigation.
Distinction from Investigational Medicinal Product
The investigational device belongs to medical device law; its counterpart on the pharmaceutical side is the investigational medicinal product. An investigational medicinal product is investigated as part of a clinical trial with medicinal products according to the Clinical Trials Regulation. It must not be equated with a medical device just because both are used in a study.
The existing glossary terms investigational-medicinal-product and investigational-medicinal-product-dossier therefore concern different product and documentation requirements. A combination project can touch upon both legal areas, for example, when a medicinal product is used together with a medical device. In such cases, the investigational item, roles, and submission documents must be determined separately for each part.
Safety and Traceability
During the clinical investigation, it must be traceable which investigational device was used at which site and in which version. Changes to the configuration can affect the safety assessment and the significance of the results. Product responsibility therefore includes not only provision and retrieval but also controlled communication of safety-relevant changes to the investigator and sponsor.
When evaluating adverse events, the connection to the investigational device is a separate question. The reporting logic distinguishes between events without an established product relation and undesirable product effects. A clear product description prevents errors in use, defects, or expected risks from being conflated in the causality assessment.
Distinction from Comparator Products
In a controlled study, a comparator product may be used alongside the investigational device. A comparator product is not automatically the object whose performance is to be demonstrated. However, a medical comparator product can also be relevant for safety reporting because an undesirable product effect may be related to its use.
The protocol documents should therefore separately explain the allocation, labeling, and handling of both product types. Only then can it later be assessed whether a result is attributable to the investigational device, the comparator, or a common study condition.
The distinction also applies to products used only for support within a study. Not every device present at the investigational site is automatically an investigational device. The clinical investigation plan must identify which product is the subject of the investigation, which products represent comparator measures, and which are only for standard care. This assignment influences product documentation, training, and the causality assessment of events.
For multi-component products, the study configuration should precisely define which combination is being investigated. For example, a catheter may be evaluated together with specific software or accessories. If components are exchanged, the tested configuration may change. The clinical data are then only transferable if the change does not significantly affect their safety or performance or is separately justified.
Release for use at the investigational site requires that the provided product corresponds to the configuration described in the investigation plan. If the assignment is not ensured, the clinical results can no longer be attributed to a clearly defined investigational item.
Relevance for clinical trials
Operational study planning for the investigational device begins with a versioned product description and does not end with delivery to the investigational site. Training materials, storage requirements, traceability, and the recording of deviations must match the specific technology. If a software update or a new accessory component is introduced, it must be assessed before use whether the investigation plan or safety documentation needs to be adapted.
Full-service CROs like Mediconomics support the creation of product-related investigational site materials, the coordination of training and supply chain, the documentation of product versions, and the evaluation of product-related safety reports in study management.
Frequently Asked Questions (FAQ)
Is a CE-marked medical device not an investigational device?
It is. The definition does not exclude CE-marked products if they are evaluated in a clinical investigation or clinical follow-up.
Can an accessory be part of the investigational device?
Yes. Insofar as the accessory is relevant for the investigated configuration and safe use, it must be clearly considered in the study documents.
What distinguishes the investigational device from the comparator product?
The investigational device is the subject of the clinical evaluation; a comparator product serves for comparison but can also be evaluated product-related in the event of safety incidents.
Regulatory References
- Regulation (EU) 2017/745 (MDR) — defines the investigational device and regulates clinical investigations.
- MDCG 2021-6 Rev. 1, Q&A on clinical investigation — explains the practical application of MDR requirements.
- MDCG 2020-10/1 Rev. 1, Safety reporting — contains terms for safety reporting.
- MDCG 2024-3, Clinical Investigation Plan — addresses product-related information in the investigation plan.
