Clinical Evaluation

Medical devices must be safe and effective. To prove this, a clinical evaluation is required. The clinical evaluation is required by both the European Medical Device Regulation (Medical Device Regulation, MDR) 2017/745 and the still valid EU Directive for Medical Devices (93/42/EEC, Medical Device Directive, MDD). This applies to every medical device regardless of its risk class, and to all medical devices from all manufacturers. In addition, a post-market clinical follow-up (Post-Market Clinical Follow-Up, PMCF) is required. The clinical evaluation is an essential part of the conformity assessment procedure for CE marking of medical devices and must be carried out to ensure approval and allow placing on the market.

With us you:

Our Approach

1. Preparation

Basic clinical data: At the beginning of the consultation, we take the time to precisely understand your company and your products. We clarify your individual requirements and goals to prepare a tailor-made strategy.

Our team thoroughly analyzes your existing clinical master data, including intended purpose, indications, patient groups, and clinical benefit information. We identify potential gaps and inconsistencies that may stand in the way of MDR compliance.

Based on our findings, we present you with clear and practice-oriented recommendations. These include necessary adjustments to design your master data correctly and precisely according to MDR requirements.

Document check according to MDR: Our consultation also includes a careful review of your existing documentation for creating a clinical evaluation according to MDR criteria. We ensure that all required information and evidence are available to confirm the conformity and safety of your medical device.

The result: We ensure that it is possible to create a clinical evaluation that meets the requirements of the MDR.

2. Clinical Data

Data collection and review: We start with a thorough data collection, where we gather and review your existing clinical data and the data of similar devices. This can include clinical studies, patient data, test results, and other relevant information.

Relevance check: Our team analyzes the collected data for its relevance to the clinical master data. We identify the indications, patient groups, and clinical benefit information that can be supported by the existing data.

Assignment and evaluation: The extracted information is then carefully assigned to the corresponding clinical master data. We evaluate the data regarding its quality and evidence base, to ensure that the master data is significant and correct.

Decision-making: After completing the analysis, we present our findings and recommendations to you. Together we evaluate whether some master data may possibly be removed from the certification of your medical device if they are not sufficiently supported by the clinical data.

Our approach aims to optimize your master data and closely align it with the existing clinical data. This not only ensures a strong foundation for certification but also strengthens the trust of customers and health authorities in the quality and safety of your product.

We understand the importance of well-founded decisions and compliance with regulatory requirements.

3. State of the Art

Data collection and evaluation: Our experts thoroughly research the state of the art concerning medical devices and identify the treatment standard in the field of use of your medical device, and alternative treatment options. We collect and evaluate relevant literature to create a solid foundation for our analysis.

PICO analysis: Based on the patient population (P), intervention (I), comparison (C), and outcomes (O), we conduct a structured PICO analysis. This allows us to capture the required search terms for the state-of-the-art research in a structured manner.

Derivation of clinical endpoints: By evaluating the collected data, we derive meaningful clinical endpoints that serve as objective standards for the efficacy and safety of your medical device.

Setting benchmarks: In addition to the clinical endpoints, we identify benchmarks and reference values. These benchmarks form the basis for the quantitative evaluation of the clinical data to prove the safety and performance of your medical device. This gives you a well-founded comparison and an objective evaluation of the results.

4. Safety Databases and PMS Data

Safety database search: We conduct an in-depth search in various safety databases where reports on adverse events and other relevant safety aspects of medical devices are recorded. This data is crucial to identify potential risks and assess the safety of your medical device.

Analysis of PMS data: Our experts evaluate the existing post-market surveillance data collected throughout the life of your medical device. This captures essential information on application, efficacy, and possible side effects.

PMCF data analysis: In addition, we look at the data from the post-market clinical follow-up to assess the performance of your medical device in real clinical application. This allows for a comprehensive assessment of clinical outcomes and contributes to improving the product.

5. Clinical Evaluation Report

The data from the state of the art, clinical data analysis, and safety database search are analyzed to prove the safety and performance of the medical device. This is followed by proof of compliance with the basic safety and performance requirements, which must be substantiated by clinical data. In addition, safety and performance are proven based on quantitative analyses using the defined benchmarks.

Clinical Evaluation

With us you:

Our Approach

1. Preparation

2. Clinical Data

We understand the importance of well-founded decisions and compliance with regulatory requirements.

3. State of the Art

4. Safety Databases and PMS Data

5. Clinical Evaluation Report

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