Clinical Evaluation Center for Devices
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What is expected of Clinical Evaluators?
The clinical evaluation should be conducted by a suitably qualified individual or a team called Clinical Evaluator(s). The Clinical Evaluator is expected to have a relevant higher education degree and five years’ related professional experience, or ten years’ professional experience if a degree is not considered a prerequisite for the task. In addition, the Clinical Evaluator(s) should possess a wide range of required competencies as listed in the table below. Deviations from these requirements should be documented and duly justified. For every device under evaluation, the manufacturers are required to define requirements for the evaluators and justify the choice of the evaluators through reference to their qualifications and experience.
Team-based Approach to Clinical Evaluation
The number of requirements placed upon the evaluator(s) indicates that a team-based approach is advisable
Finding one person with experience, expertise, and knowledge to fulfill every aspect of the evaluators’ role is highly unlikely in most circumstances. Anyone who undertakes the identification, appraisal, and analysis of a data set included in the clinical evaluation should be considered an evaluator
Clinical evaluation may be performed anywhere providing the evaluators have access to the necessary information and documentation
It can be performed in-house solely by the manufacturer with involvement from employees at one or more sites. However, it is often performed in conjunction with external parties (e.g. medical writers, consultants)
Ultimately, clinical evaluation remains the responsibility of the manufacturer and the CER is part of the technical documentation
Our Clinical Evaluators
CECD encompasses a strong team of Clinical Evaluators with relevant education and adequate experience. Our Clinical Evaluators who sign the CER are responsible for its contents. Our team of Clinical Evaluators includes:
CER Writer - The CER Writer plays a key, coordinating role. The CER Writer must have the ability to evaluate and interpret pre-clinical data and the ability to collect, appraise and analyze clinical data (including expertise in literature search protocols, database searching, and research methodology)
Device Specialist – Often the R&D Manager involved in the development of the device, therefore possessing knowledge of device technology and its applications
Clinical Specialist – A medically-qualified physician or nurse with clinical expertise in the relevant medical specialty provides key input for evaluating clinical use of the device and the state of the art
Experts Providing Input into Clinical Evaluation
The clinical evaluators (signatories to the CER) receive input from various experts. Experts who may be involved are listed below, together with a description of their roles. In some circumstances, it may be appropriate for an expert to act as a signatory to a CER.
Biological Evaluator – An individual involved in performing biological and biocompatibility evaluation
Quality/Risk Management Specialist – A professional with an understanding of risk management principles. The MDR stipulates that “the risk management system should be carefully aligned with and reflected in the clinical evaluation for the device. The risk management and clinical evaluation processes should be inter-dependent and should be regularly updated
Regulatory Specialist – The regulatory specialist has an important role in checking device labeling requirements, claims made about the device, and PMS and PMCF requirements
Preclinical R&D Specialist – A biomedical scientist with knowledge of pre-clinical studies, implementation, and interpretation
Clinical Research Specialist – A clinical scientist with knowledge of pre- and post-market clinical investigations
External Expert Panels – Under MDR, for Class III devices and for active devices intended to administer and/or remove a medicinal product, a manufacturer should be able to consult voluntarily an expert panel, prior to initiating the clinical evaluation
Usability Engineering Specialist – An engineer with an understanding of usability engineering. The specialist knowledge must be relevant to the particular device
The interaction between our Clinical Evaluators and the Experts is pictorially represented below:
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