A poorly planned clinical strategy, a clinical investigation that does not comply with ISO 14155, an incomplete clinical evaluation, or an insufficiently substantiated DIV performance evaluation can delay your CE marking by several months. Our regulatory and clinical experts help you build a robust, proportionate, and defensible clinical dossier or performance dossier.
Develop a clinical strategy tailored to your device
We work with you to define the most efficient clinical pathway for demonstrating the safety and performance of your device, in line with its risk class and intended use.
Our support may include:
- An analysis of the state of the art and the system’s positioning;
- Identifying Available Clinical Data and Missing Data
- Defining the clinical demonstration strategy: literature review, demonstration of equivalence, proprietary clinical data, use of a clinical investigation, application of Article 61(10) when this approach is justified, or consideration of Well-Established Technologies (WET) when your device falls under a well-established technology;
- Defining the clinical development plan;
- Planning for post-marketing clinical follow-up, or PMCF;
- Anticipating the expectations of the notified body and the competent authorities.
The goal is to develop a proportionate, robust, and defensible clinical strategy that is consistent with regulatory requirements and the characteristics of the device.
Clinical Investigation
When a clinical trial is necessary, we assist you with its design, regulatory setup, and monitoring, in strict compliance with good clinical practices.
- Drafting of the protocol, the investigator’s brochure, and the CIP
- Filing with the ANSM, the CPP, and the relevant competent authorities
Clinical Evaluation of Medical Devices
Drafting and Updating the CEP and CER
We draft, review, and update your clinical evaluation plans and reports in accordance with the requirements of Annex XIV of Regulation (EU) 2017/745 to demonstrate the clinical conformity of your medical devices.
Our services may include:
- Drafting or reviewing the clinical evaluation plan (CEP);
- A review of the scientific literature;
- Analysis of the state of the art;
- An analysis of the available clinical data on the device;
- A demonstration of equivalence, when this approach is applicable and justifiable;
- Assessment of the risk-benefit ratio;
- Drafting or updating the clinical evaluation report (CER);
- Verification of consistency with the technical documentation, the risk management dossier, the information provided to the user, and post-market surveillance;
- Preparing responses to the notified body’s questions.
The goal is to have a CEP and CER that are well-structured, well-reasoned, and consistent with the manufacturer’s claims, the device’s intended use, and the available data.
Post-Marketing Clinical Follow-Up (PMCF)
Postmarket clinical follow-up helps confirm the safety and performance of the device under real-world conditions, identify emerging risks, and keep the clinical evaluation up to date.
We can assist you with:
- Define the PMCF strategy;
- Draft or review the PMCF plan;
- Identify PMCF activities appropriate for the program;
- Analyze data from the market, complaints, the literature, or records;
- Update the clinical evaluation report;
- Ensure consistency with the PMS, the PSUR, and risk management.
Performance Evaluation of In Vitro Diagnostic Medical Devices
Drafting and Updating the PEP and PER
For in vitro diagnostic medical devices, we assist you in compiling the performance dossier required by Regulation (EU) 2017/746.
Performance evaluation is based on three pillars: scientific validity, analytical performance, and clinical performance. These elements must demonstrate that the device achieves the claimed performance for its intended use and that the available data are sufficient to support its compliance.
Our support may include:
- Drafting or reviewing the performance evaluation plan (PEP);
- Demonstration of scientific validity;
- Analysis of analytical performance;
- Analysis of clinical performance;
- Drafting or reviewing the performance evaluation report (PER);
- The preparation or review of performance studies;
- Consideration of human biological samples, where applicable;
- Consistency with the technical documentation, the risk management dossier, the information provided to the user, and the PMS;
- Preparing responses to the notified body’s questions.
Post-Market Performance Monitoring (PMPF)
Post-market performance monitoring helps confirm the scientific validity, analytical performance, and clinical performance of the IVD throughout its lifecycle.
We support you in:
- Defining the PMPF strategy;
- Drafting or reviewing the PMPF plan;
- Identifying the data to be collected after the product is launched;
- Analysis of data from real-world use of the device;
- Updating the performance evaluation report;
- The integration with post-market surveillance, vigilance, and risk management.
How We Work
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Diagnosis
Analysis of the device, its risk class, and the clinical data already available. -
Strategy
Defining the clinical pathway and regulatory timeline tailored to your market launch objectives. -
Execution
Conducting the clinical investigation and/or drafting the clinical evaluation dossier. -
Follow-up
Ongoing updating of the CER and management of the PMCF throughout the product's lifecycle.
Frequently Asked Questions About the Clinical Component
Clinical evaluation is the ongoing process of analyzing all available clinical data to demonstrate the safety, performance, and risk-benefit profile of a medical device. It may draw on various data sources, such as the scientific literature, data from equivalent devices, the manufacturer’s own clinical data, or the results of a clinical investigation.
A clinical investigation, on the other hand, is a study conducted in humans in accordance with Regulation (EU) 2017/745 and ISO 14155. Its purpose is to generate new clinical data when existing data are insufficient to demonstrate the device’s compliance.
In summary, clinical investigation is a means of generating clinical data, while clinical evaluation is the overall process of collecting, analyzing, and interpreting all of this data to demonstrate the clinical compliance of the medical device.
No. The decision to conduct a clinical investigation depends, among other things, on the device’s risk class, its degree of innovation, the available clinical data, and the chosen strategy. In certain cases, a demonstration based on the scientific literature, equivalence, or the provisions of Article 61(10) of the MDR may be considered, provided it is duly justified.
Article 61(10) provides that, in certain specific situations, demonstration of compliance with the general safety and performance requirements may be based on elements other than clinical data. This approach must be scientifically justified, consistent with the intended use of the device, and accepted by the notified body when its involvement is required.
A Well-Established Technology (WET) is a technology whose characteristics, performance, and safety profile are well documented. MDCG Guidance Document 2025-6 specifies the criteria for identifying these technologies and their impact on the clinical demonstration strategy. However, a WET does not exempt a manufacturer from conducting a clinical evaluation in accordance with the MDR.
Post-market surveillance (PMS) covers all information collected on a device after it has been placed on the market (complaints, vigilance reports, feedback, literature, etc.). PMCF is a specific component of PMS, focused on collecting additional clinical data when necessary.
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Isocèle Conseil assists you in defining, drafting, reviewing, and updating your clinical and performance dossiers for medical devices and in vitro diagnostic medical devices.
Contact us to discuss your clinical or performance project.