Data Generated by the Manufacturer

Within the Clinical Evaluation Plan (CEP), the core objective of this chapter is to clearly and concisely outline the data that has been directly generated, is held by, or is directly accessible to the manufacturer, and which will serve as critical evidence in the clinical evaluation. This section aims to showcase to authorities the existing internal evidence base accumulated through the manufacturer’s activities in support of the medical device’s safety, performance, and conformity. It constitutes a significant component of the clinical evaluation data and provides a solid starting point for subsequent data analysis and conclusion drawing.

When drafting this chapter, the focus should be on inventorying and summarizing existing internal data, ensuring the accuracy and traceability of the information.

Summary of Preclinical Study Data

Preclinical study data is fundamental to establishing the safety and functional basis of the device. The CEP should provide an overview of these completed studies and their main conclusions.

• Firstly, conformity of the device under evaluation with relevant product standards (e.g., specific harmonized or industry standards) during its design and manufacture should be confirmed.
• Next, a summary of the results from executed Verification and Validation (V &V) activities is required. This includes bench tests, performance tests, mechanical integrity tests, electrical safety tests (if applicable), and software validation (if applicable) aimed at demonstrating that the device design output meets design input requirements and that its design is adequate for the intended clinical use. It should be generally stated how the results of these tests confirm the device’s functionality and safety.
• Biocompatibility assessment is a critically important aspect. A brief overview of the scope and conclusions of biocompatibility assessments conducted for the device under evaluation (particularly for parts in direct or indirect contact with the human body) should be provided, typically stating that assessments were performed according to relevant standards such as the ISO 10993 series. It can be mentioned that supporting documentation (like specific test reports and biological evaluation reports) is available in the technical documentation for review.
• If preclinical animal studies were conducted for the device under evaluation, an overview of the objectives of these studies (e.g., to assess acute and/or chronic in-vivo responses, preliminary safety and efficacy), the animal models used, key observation parameters, and principal study outcomes should be provided.
• For all mentioned preclinical studies, the CEP need only provide conclusive summaries, and it should be clearly stated that detailed study reports and data will be presented and analyzed more comprehensively in the Clinical Evaluation Report (CER).

Summary of Manufacturer-Sponsored Clinical Investigation Data (if any)

If the manufacturer has sponsored or is sponsoring any clinical investigations for the device under evaluation (whether completed, ongoing, or in early planning stages with some data available), this section should provide relevant summary information.

• For each study, briefly state its current status (e.g., completed, data analysis in progress, subject recruitment ongoing).
• If preliminary or final study results are available, outline the main findings and conclusions related to device safety and performance.
• Similarly, it should be indicated that full clinical study reports will be reviewed in detail in the CER.

Summary of Post-Market Surveillance (PMS) and PMCF Data (if applicable)

If the device under evaluation (or a very similar predecessor model from the same manufacturer) has a history of being marketed and used in any region (including outside the EU), this section should summarize the relevant data collected through PMS and PMCF activities.

• An overview of its market application can be provided first, such as regions where it is marketed, sales volume or approximate number of clinical applications, and duration of market presence.
• Subsequently, safety data collected from these real-world applications should be summarized, such as the types and numbers of user complaints received, adverse event reports (including severity and frequency), and any related vigilance activities or corrective/preventive actions. If the volume of data or level of detail is extensive, a tabular format can be used for summarization, presenting key trends or summary findings in the CEP.
• If specific PMCF studies or activities (like the aforementioned PMCF survey, registry study analyses, etc.) have been conducted and completed, their main results should also be outlined here.
• If the device under evaluation is entirely new and has no market history, this should be clearly stated. However, it can also be mentioned that the manufacturer has established procedures and plans for post-market surveillance and clinical follow-up, which will be implemented to collect and analyze relevant data after the device is launched.

Clarification on the Positioning of Literature Search Data

It is important to note that the core focus of this chapter is to summarize data “generated and held by the manufacturer.” Regarding data obtained through systematic literature searches , the detailed search strategy, list of databases, search terms, inclusion/exclusion criteria, literature screening process, and quality assessment methods should typically be detailed in the methodology section of the CEP (A dedicated (https://reguverse.com/documentation/clinical-evaluation/cep/文献检索计划lsp/)).

This chapter (“Summary of Data Generated and Held by the Manufacturer”) primarily focuses on data directly resulting from the manufacturer’s own R&D, testing, manufacturing, and post-market monitoring activities. If the manufacturer maintains an internal, curated library or database of relevant scientific literature specifically for the device or device family, its existence as a significant information resource held by the manufacturer and its role in the clinical evaluation could be mentioned at a high level here.

Data Accessibility and Traceability

When summarizing these various types of data, the CEP should convey a clear message: all mentioned data generated and held by the manufacturer is supported by corresponding original records and reports. These documents will be available for detailed reference, analysis, and assessment in the subsequent Clinical Evaluation Report (CER).