Compilation of Clinical Evaluation for Medical Devices orPerformance Evaluation for in vitro diagnostic medical devices

Medical Device manufacturers who wish to place their device on the European market are legally obliged, (among others) by the provisions of the Article 5 of the EU 2017/745 (MDR), to include a Clinical Evaluation, when demonstrating compliance to the General Safety and Performance Requirements of the aforementioned regulation.

Similarly, for in vitro diagnostic medical devices (IVDs), demonstration of conformity with the general safety and performance requirements shall include a performance evaluation in accordance with Article 56 of the EU 2017/746 regulation (IVDR). A performance evaluation shall follow a defined and methodologically sound procedure for the demonstration of scientific validity, analytical and clinical performance.

Both Clinical (CER) and Performance Evaluations are systematic and planned processes to generate, collect, analyze and assess pre-clinical and clinical data pertaining to a device, to continuously verify, whether its safety, performance and clinical benefits correspond to those claimed by the legal manufacturer, when the device is used as intended.

Formal output of both of the aforementioned processes is summarized in a report format. Clinical and Performance Evaluation Reports, respectively, are both “living documents”, and as such, their content shall cover all relevant stages of the device life cycle, starting from design validation and verification activities, through pre-market clinical studies, to periodic and triggered updates in the post-market phase.

Both of the reports are not only formally required for any device risk class but are also considered a focal point of every medical device technical documentation. This is because they are de facto a repository of all relevant pre-clinical, as well as clinical evidence, which are intended to argue advantageous risk-benefit ratio of the corresponding device, as compared to alternative medical therapies, similar devices or diagnostics. In addition, both documents insight, to any reviewer, on the general condition of the processes deployed within the manufacturer’s quality management system (QMS), including among others risk analysis, clinical operations, design and development, or Post Market Surveillance (PMS) etc.

From the risk-based approach standpoint, it is therefore highly advisable for each medical device legal manufacturer in EU (and other applicable geographies), to make sure adequate due diligence practices are employed, when Clinical or Performance Evaluations are to be compiled and maintained later on.

Ce mark, Medidee Medical Services

Medidee assembles a full scientific team dedicated to preparing high quality Evaluations covering all relevant aspects, required by both state of the methodology (e.g. MEDDEV 2.7/1 rev4), and current regulations (MDR or IVDR). Each Evaluation is compiled following carefully defined and validated strategy, taking into consideration device intended purpose, outcome of risk analysis, nature of the interaction with the human body (if any), and the complexity of the claims advanced by the legal manufacturer. Based on this strategy, clinical data review and appraisal methodology is meticulously established and defined in the Clinical Evaluation Plan (CEP) or Performance Evaluation Plan (PEP), which are subsequently executed to compile accordingly Clinical Evaluation Report (CER) of Performance Evaluation Report (PER), summarizing all relevant and objective evidence supporting claims issued by the manufacturer, as per device’s intended purpose.

The key success criterion with regard to the activities outlined above, is the ability of the Medidee’s Clinical Team to capture the detailed design, regulatory and quality aspects specific to the product covered by the scope of each performed Evaluation. As each Evaluation mandate is unique in its nature, also the support of Medidee is always adapted to the specific needs of our client. As per individual request, we can either offer a full work package including delivery of a turnkey Clinical or Performance Evaluation documentation, or may focus on their specific aspect related to strategic coaching, final document review, or even formal gap assessment.

team, Medidee medical services

Throughout the years, Clinical Team of Medidee has collected a vast experience in preparation of this type of Evaluations, with team members having authored approximately 200 Clinical Evaluation Reports for devices of all risk classes and from various medical fields. As such, no matter what the nature of your product is, we definitely know the proper way around, to help you collect robust and good quality clinical evidence, that support its unique benefits and unmet medical needs.

Medidee’s Clinical Services are formally covered by the scope of our ISO 13485 QMS certification, which ascertains provision of supreme quality end product through implementation of the following practices:

EACH Evaluator at Medidee holds high education degree and is formally trained on the Clinical Evaluation Methodology, as per current state of the art practices, and internal processes by the Subject Matter Experts

EACH Clinical or Performance Evaluation process is formally supervised by an assigned Project Manager. This one of its kind dual-review procedure ensures overall process compliance and implementation of all relevant Quality Control procedures

EACH Evaluation strategy is defined on case by case basis, and is formally validated by the client, based on extensive communication and interaction