Clinical Evaluation of Medical Devices

To demonstrate that medical devices are safe, and their performance is ‘state of the art’ in line with their clinical intended use, medical device manufacturers must perform clinical evaluation. Clinical evaluation is a requirement of the Medical Device Regulation 2027/745 in the European Union and the UK medical device regulations 2002 in the United Kingdom. Clinical Evaluation forms part of the regulatory requirements that must be met before a manufacturer can apply the CE mark in the EU and the UKCA mark in the UK to their medical devices, and then place them on those markets.

Clinical evaluation is a review of all the evidence that has been generated by the manufacturer, from verification and validation activities in the design and development phase and manufacturing phases, including, validation against harmonised standards used to demonstrate conformity, biological evaluation, software validation, sterility validation and so on, relevant to the medical device. It also encompasses a review of any clinical data pertinent to the medical device in the form of published clinical data on the device itself or on similar devices on the market, that can be used to indicate a devices performance and safety. It also reviews any non-published clinical studies or data generated by the manufacturer and assesses the risk management documentation generated by the manufacturer as well as the information provided to the user by the manufacturer, such as, instructions for use and labelling.

The purpose of the clinical evaluation is to assess the device to see if the sum of the data generated to demonstrate safety and performance outweigh the risks of using the medical device.
Clinical Evaluation is a continual process, for the lifetime of the medical device.
The first stage of clinical evaluation is the clinical evaluation plan. The clinical evaluation plan establishes how a manufacturer will perform clinical evaluation. This includes how any scientific literature searches will take place and the methodology and research methods adopted to ensure that clinical data is being searched for follows a valid scientific method. The plan will set out the scope of the clinical evaluation and determine what type of data will be used to perform clinical evaluation. It will identify the relevant regulatory requirements that are applicable to the device in demonstrating performance and safety.

Once the plan has been executed, the manufacturer must gather all the relevant pre-clinical data needed to support the clinical evaluation, clinical literature searches should take place using relevant clinical publication sources such as PUBMED and the Cochrane Library, or device/clinical area specific journals, or the unpublished results of clinical trials/studies that have been conducted on the medical device being evaluated.

Medical device clinical evaluation should be carried out by suitably qualified experts on the subject device, this usually consists of a multidisciplinary team of experts with clinical knowledge, medical device specific knowledge from the design and manufacturing team, risk management team and regulatory and quality experts.

Once all the data has been assessed and critically reviewed it should be presented in the form of a clinical evaluation report. The report should be a critical analysis of all the supporting pre-clinical and clinical data generated to support that the benefit of using the medical device out weighs the risks of using the medical device when considering its intended use.

All medical device regardless of their classification must undergo clinical evaluation. For medical devices that are completely novel or legacy devices are being used within a new intended use for which there is no clinical history, it is usually expected that these devices undergo clinical trials to generate supporting clinical evidence that the intended use meets the state of the art.

Once a device has been placed on the market, medical device manufactures need to update their Clinical Evaluation on an ongoing basis. This encompasses any new data that has been generated since the last clinical evaluation. Clinical Evaluation is expected to be performed at least on a 2 yearly basis or depending on the level of risk associated with the medical device. Data generated from Post Market Surveillance reports or Periodic Summary Reports should be included in the updated review, and information from Post Market Clinical Follow-up Reports.

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