Despite the fact that regulatory authorities assign them exact, distinctly different definitions, a number of phrases with similar meanings under the plethora of rules and standards governing medical devices frequently get used interchangeably inside the sector.
Even among those who work with medical devices, the terms “clinical evaluation” and “clinical investigation,” which are completely different, are frequently used interchangeably. Since “evaluation” and “investigation” have similar meanings and are frequently used synonymously outside of the medical device business, the cause is rather obvious.
In order to assist you in understanding what you, as the producer, must do for each procedure to be successful in acquiring a CE marking, this guide will explain the distinction between clinical assessment and clinical investigation when applied in the context of medical devices.
What is a clinical assessment or evaluation?
A CE mark, which serves as official documentation that the product has complied with strict safety, health, and environmental criteria, must be obtained before a medical device maker may sell it on the EU market.
As part of the CE marking procedure, which it defines as, the EU Medical Device Regulation (EU MDR) mandates that medical device manufacturers do a clinical review of their product.
A methodical, well-thought-out procedure for regularly generating, gathering, analysing, and evaluating clinical data related to a device in order to confirm the device’s safety, performance, and clinical advantages when used in accordance with the manufacturer’s instructions.
In order to demonstrate that they have conducted a medical device clinical evaluation and that it has established the product’s safety and efficacy, medical device makers are required by MDR to submit a Clinical Evaluation Report (CER).
The European Commission (EC) has made available a clinical evaluation guidance document, the most recent version of which is known as MEDDEV 2.7.1, to assist medical device makers in complying with these specific regulations’ criteria.
What distinguishes a clinical investigation from a clinical evaluation?
Clinical study describes a methodical clinical trial of a medical device that employs human subjects to judge the device’s safety and/or effectiveness.
A clinical evaluation is always required, so keeping this in mind will help you distinguish between it and a clinical investigation. It may result in a clinical investigation if more clinical evidence is required to demonstrate the safety and efficacy of a device, but this step is not always necessary.
Most low- to medium-risk devices won’t require a clinical evaluation because there is probably already plenty of clinical data that can be gathered and analysed to demonstrate the device’s safety and efficacy.
Following are indications of possible clinical investigation needs for your device:
- Fresh design elements or materials
- A different objective
- Making fresh assertions about the gadget
- Different user types
- Significant hazards, both direct and indirect.
- Embedding or coming into contact with mucous membranes
- An increase in the number or duration of reapplications
- Incorporation of pharmaceuticals
- Use of animal tissues not in skin-contact applications
- Existence of newly identified dangers, alternatives with lower risks or greater rewards, or both
How to write a clinical evaluation report
Scoping: During this preliminary stage, the clinical evaluation’s context will be established. This stage will also take a close look at the device that is being evaluated in order to comprehend and define how it functions.
Identification of relevant data: It will describe the pre- and post-market clinical data they will use to conduct the clinical evaluation in this stage.
Data appraisal: It involves determining the validity and relevance of the pertinent information that has been gathered for the clinical evaluation.
Clinical data analysis: This phase entails the analysis of the data gathered. In addition to determining if the equipment complies with safety and performance criteria, evaluators will also look for any ambiguities or unsolved concerns.
Producing the clinical evaluation: The creation of the CER, which summarises all earlier phases and the findings made by the assessors, is the last stage.
Once a product has a CE mark and is put on the market, it must undergo ongoing clinical evaluation with updated reports through post-market surveillance and the observation of fresh clinical data.