Key Requirements of Clinical Evaluation Process according to EU MDR 2017/745

The criteria for clinical evaluation of medical devices have undergone a considerable revision as a result of the European Union Medical Device Regulation (EU MDR) 2017/745, which supersedes the Medical Devices Directive (MDD) 93/42/EEC. This article's objective is to give a general overview of the clinical evaluation procedure as per EU MDR 2017/745.

Overview of the Clinical Evaluation Process:

Clinical data produced by the usage of a medical device are evaluated as part of the clinical evaluation process. Clinical evaluation is described as "a systematic and structured procedure to continually develop, collect, analyse, and analyse clinical data on the safety and performance of a device" by the EU MDR.

The clinical evaluation process includes the following steps:

Clearly define the medical device's intended use:
The medical device's intended use needs to be stated. The target audience, surroundings, and indications for use of the gadget must all be taken into account.

Determine the pertinent clinical data:
It is important to identify the clinical data that will be used in the evaluation. This includes information from post-market surveillance, published literature, clinical studies, and any other pertinent sources.

Evaluate the clinical data's quality:
The strength, applicability, and dependability of the data should be taken into consideration while evaluating the clinical data's quality.

Examine the clinical data:
To ascertain the device's performance and safety, the clinical data should be examined. The evaluation of the device's risks, advantages, and any potential negative occurrences should all be part of the analysis.

Make inferences:
Inferences should be made about the device's performance and safety based on the examination of the clinical data.

Update the clinical evaluation:
To make sure that the clinical data is current and pertinent, the clinical evaluation should be updated frequently.

Key Requirements of the Clinical Evaluation Process:

Clinical Evaluation Report (CER):
Each medical device must have a clinical evaluation report (CER), according to the EU MDR. A thorough summary of the clinical data utilised in the evaluation and the findings from the data analysis should be included in the CER.

Clinical Evaluation Plan (CEP):
A clinical evaluation plan (CEP) must be created for each medical device, according to the EU MDR. The CEP should provide a detailed description of the clinical evaluation plan, including the device's intended use, the clinical data that will be used, and the techniques used to evaluate and analyse the data.

Expertise:
A person or group of people doing the clinical evaluation should have the necessary experience in the pertinent clinical area, regulatory requirements, and clinical evaluation technique.

Post-market surveillance (PMS):
According to the EU MDR, the clinical evaluation must be founded on data gathered during the device's whole lifecycle. Data from post-market surveillance initiatives including addressing complaints, disclosing adverse events, and other user input are included in this.

Data protection:
The clinical data included in the evaluation must be obtained and processed in line with the relevant data protection regulations, according to the EU MDR.

Conclusion:

The regulatory licencing procedure for medical devices includes a crucial step called clinical evaluation. The criteria for clinical evaluation have undergone a considerable revision as a result of the EU MDR 2017/745, including the requirement for thorough CER and CEP, the participation of experts with the necessary knowledge, and the utilisation of clinical data from post-market monitoring operations. To guarantee the safety and effectiveness of their products, medical device makers must ensure that they adhere to the EU MDR's standards.

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