The documents a device investigation draws on and feeds

A clinical investigation of a medical device runs on documents of its own and sits among the device's other documents: it takes content from the clinical evaluation, post-market, risk management and labelling documents, and its results flow back into them and into the documents written for the public.

The investigation's own documents

A clinical investigation plan describes how the investigation is conducted, the statistical analysis plan prespecifies the statistical analysis to be performed, and the informed consent form summarises the investigation for the patient. ¹ At the end of the investigation, or at specific time intervals, a clinical investigation report, final or interim, is created. ^{1, 2}

What the investigation draws on and feeds

The investigation is an instrumental part of the device's clinical evaluation, except for low-risk devices, for which an investigation might not be necessary. ² It derives content from several other documents and in turn becomes a reference for updating them. ² The documents related to an investigation include: ³

• the clinical development plan, which describes the device's clinical strategy and is part of the clinical evaluation plan; investigations must be conducted according to it, but information obtained from them may also feed back to it ⁴
• the clinical evaluation plan, which plans the clinical evaluation and contains the clinical development plan; the clinical evaluation assesses the device's clinical data to verify its clinical safety and performance, and information from an investigation, such as its outcomes and areas that require further investigation, may feed back to the plan ⁴
• the clinical evaluation report, which reports the outcomes of the clinical evaluation; investigations are an integral part of it and their reports are often attached to it, and the report may also feed into an investigation, for example where it identifies gaps that need to be covered through an investigation ⁴
• the health economic assessment, into which data from an investigation, such as quality-of-life questionnaires, length of hospital stay and operation time, may feed, particularly for novel devices whose reimbursement still has to be established ⁴
• the investigator's brochure, which summarises all preclinical and clinical data of the device and is required for investigations with investigational devices; for an investigation with an approved device the instructions for use usually suffice ⁴
• the instructions for use, the packaging leaflet that describes how to use and store the device and its potential complications; they are required for investigations, and information obtained in investigations may feed into them, for example where new complications have been identified ⁴
• marketing documents, the communications to the public such as websites and brochures, in which every clinical claim needs to be substantiated with clinical data ⁴
• the post-market clinical follow-up plan, which specifies the collection and evaluation of clinical data and includes investigations as well as literature screening and other activities; investigations must be conducted according to it, but their outcomes may also feed into it ⁴
• the post-market clinical follow-up report, which summarises the outcomes of follow-up investigations among the other follow-up activities ⁴
• the post-market surveillance plan and report, into which the outcomes of investigations, such as incidents, may feed ⁴
• the periodic safety update report, which summarises the outcomes of the post-market clinical follow-up together with data from other sources, such as complaint data ⁴
• publication: the results of every investigation should be published in a peer-reviewed journal, and at least the outcomes must be made publicly accessible ⁴
• entries in public databases: investigations need to be registered in public databases, which may also contain their outcomes ⁴
• the Summary of Safety and Clinical Performance, which provides an update on the device's safety and performance, summarises its clinical data and must be made available to the public, via EUDAMED once the database is live; identified gaps may feed into the design of new investigations ⁴
• risk management documents, which feed into several other documents, such as the instructions for use, that have to be considered when writing a clinical investigation plan, particularly for risks, precautions and warnings; the outcomes of investigations may likewise feed into risk management, for example as event rates, new risks and new precautions ⁴

Not every document related to an investigation is required for every medical device. ³