Clinical evaluation of medical devices
The clinical evaluation is part of the technical documentation of a medical device and is prepared as part of the conformity assessment procedure.
Based on data from clinical investigations, post-market surveillance observations and/or a scientific literature search, TentaConsult documents the efficacy or functionality and the safety in use of medical devices – across the entire life cycle of a medical device. Even after a product has been placed on the market, TentaConsult takes care of the regular review and update of the clinical evaluation for the required Post Market Surveillance (PMS) through the Post Market Clinical Follow-Up (PMCF)
The Biological Evaluation Plan (BEP) as the basis for biocompatibility testing
As part of the biocompatibility assessment, we define the analytically meaningful procedures for evaluating the biological safety of a medical device in the Biological Evaluation Plan (BEP). The type and scope of the necessary tests can vary considerably depending on the product's characteristics. From the wide range of possible biocompatibility tests, however, by no means every test is required for every product: the extent of testing required is assessed individually and on a risk basis, which allows it to be designed efficiently. The BEP is therefore part of the risk management for medical devices in accordance with ISO 14971. Ideally, we discuss with our customers as early as the development phase which characteristics their product will have and which tests are necessary for this – and which data can already be supported by references to the literature.
The Biological Evaluation Report (BER) for classifying biocompatibility data
A Biological Evaluation Report (BER) explains and justifies which biocompatibility tests were carried out – and which were not. In addition, the BER documents and evaluates the results of the biological tests. In our MDR-compliant Biological Evaluation Reports, we combine data from tests carried out with data from the scientific literature, arriving at a validly substantiated statement on the biological risk analysis.
The Clinical Evaluation Plan (CEP) as the basis for the clinical evaluation
The methodology and scope of the clinical evaluation must be tailored to the respective product and its intended purpose, and must be comprehensible and well-founded. We always structure the content of the clinical evaluation in accordance with the Medical Device Regulation (MDR) and the MEDDEV guidelines, which are recognised by the Notified Bodies. In addition to the intended purpose of the medical device as well as the objective and methodology of the clinical evaluation, the individual chapters of the clinical evaluation list the underlying data sources and analyse and evaluate the significance of the data used. A carefully prepared Clinical Evaluation Plan (CEP) forms the basis for their selection and analysis."
The Clinical Evaluation Report (CER) as documentation of clinical evidence
The conceptual argumentation from the Clinical Evaluation Plan, various sources of clinical data, and their analysis and assessment, are ultimately brought together in the Clinical Evaluation Report (CER). This report documents and substantiates the clinical evidence of the safety and the medical-technical performance of a medical device."
Eudamed: Summary of Safety and Clinical Performance (SSCP)
For medical devices in a higher risk class, so-called "summary reports" on safety and clinical performance are mandatory and must be made publicly accessible to clinicians and patients in the European database for medical devices (Eudamed). We prepare and word the SSCP in clear, comprehensible language in accordance with the guidelines of the Medical Device Coordination Group (MDCG).
The fundamental clinical requirements for medical devices also apply to in-vitro diagnostics. However, these are regulated by their own directive, the IVDR. [Link sollte auf die entsprechende, noch anzulegende englische IVD-Seite verweisen, siehe eigener Befund zur IVD-Seite]"