What is a Clinical Evaluation?
Clinical Investigation is a systematic study performed in humans to access the safety and performance of a medical device based on the comprehensive analysis of available preclinical, Clinical (Safety), and post-market data relevant to the intended purpose of the device.
Clinical evaluation is a process to continuously generate, collect, analyze and assess the clinical data about a medical device under evaluation to prove the conformity with general safety and performance requirements as per its intended use by the manufacturer.
Clinical evaluation is an ongoing process and is first conducted during the development stage of a medical device throughout its life cycle.
Clinical Evaluation Process Under EU MDR!
Today we will share the clinical evaluation process under the European medical device regulation EU MDR. We will begin by outlining the regulatory background process and defining key terminologies.
The clinical evaluation process is an important part of conformity assessment for all medical devices, regardless of which risk classification they fall under. It is also closely linked to the risk management process and post-market surveillance activities. This page will clarify and emphasize these parallels throughout each step of the process.
Let’s begin by clarifying the regulatory background and key terminologies for medical device regulations, and other documents, all of which manufacturers must take into account throughout the clinical evaluation process.
As per the medical device regulation, MDR clinical data refers to any data about the safety and performance of a medical device and can be obtained from multiple sources.
The most powerful and determining sources of data are derived from well-designed clinical investigations of the device in question. However, before beginning to plan such an investigation, manufacturers must first identify any current existing data that may be relevant to determining the safety and performance of the device.
Scientific Literature Search & Risk Analysis
Clinical investigations reported in the scientific literature of a similar device. These similarities will be discussed in detail later on, published scientific literature from other clinical experiences or usages, indications of the device in question, or a relevant similar device.
Once a device is on market data from the post-market surveillance activities, particularly post-market, clinical follow-up efforts must also be included in the clinical evaluation report.
Before jumping into the first step of the clinical evaluation process, creating a plan, let’s review some important prerequisites. Before a clinical evaluation can begin, several essential prerequisites must be met.
The intended use must be clearly defined in terms of the target patient population, a thorough risk assessment must be conducted to define safety claims resulting from a full benefit-risk analysis of the medical device within the defined intended use.
Technical File and Labelling
To begin, it is first important to define the intended use of the device as safety and performance claims are specific to that use.
The intended use will be identified on the label instructions and any other promotional materials or statements from the manufacturer and must align with the technical file and all labeling and communication materials.
Safety and performance claims can only be established after an intended use has been given. For example, the safety profile of a vascular balloon catheter will differ from that of a peripheral vascular or coronary intended use. Furthermore, a medical device may have different technical characteristics based on the intended use. Risks may vary and performance claims may differ.
The definitions provided in the article itself shows the difference between Clinical Investigation and Clinical Evaluation, i.e. Clinical Investigation is the study conducted on humans to demonstrate the safety and performance of the device whereas Clinical Evaluation is a critical evaluation of clinical data from scientific literature or post-market clinical data or clinical data from Clinical Investigation or a combination of all the three, thereof.
Some of the other major differences between the two are as follows:
Clinical Evaluation is mandatory as per ISO 13485 – Medical Device Quality Management System (cl. 7.3.7) and as per EU MDR 2017/745 for CE marking, whereas Clinical Investigation is mandatory only if the available data are not sufficient to demonstrate safety and performance of the device, irrespective of the risk class of the device. All Clinical Investigations need to be approved by the Ethics committee, by rule, and by the Competent authorities of those countries involved.
Clinical Evaluation can be performed by qualified and experienced clinical evaluators, consultants, or regulatory professionals whereas Clinical Investigations are usually performed by Clinical Research Organizations (CRO), who have in-depth knowledge of medical device rules and regulations and abides by ISO 14155.
In the EU MDR, Article 61 and part A of Annex XIV and Meddev 2.7/1 Rev.4 specifies the requirements for Clinical Evaluation. In the EU MDR 2017/745, Article 62 to 81 and Annex XV, ISO 14155, and Meddev 2.7/4 specify the requirements for Clinical Investigation.
Clinical Evaluation is required in order to certify the device, approve and place it in the market. Clinical evaluation of a medical device can either be based on the relevant scientific literature or clinical investigation results or based on both.
Clinical investigation is must, in case of high risk and implantable devices with few exceptions. For other devices clinical investigation is required if the available clinical data is not sufficient to prove the safety and performance of device.
Clinical evaluation is conducted to prove the conformity with general safety and performance requirements of subject device as per its intended use and current state of art with purpose to launch drug in market.
For this required Clinical data are assessed during clinical investigations and collected, appraised and analysed during clinical evaluation on ongoing basis throughout the lifecycle of device.
Clinical investigation is the clinical study in humans carried out to assess the safety, performance and clinical benefits of the device under the following circumstances:
– address gaps in available clinical data that cannot be addressed in any other way (e.g. when new technology is used)
– Class III and implantable devices which do not satisfy the exclusion criteria [Article 61(4) of MDR]