Clinical Evaluation and Clinical Investigation
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 pertaining to a medical device under evaluation to prove the conformity with general safety and performance requirements as per its intended use by manufacturer.
Clinical evaluation is an ongoing process and first conducted during the development stage of medical device throughout its life cycle.
Any one have a better explanation to understand the major differences between Clinical Evaluation and Clinical Investigation?
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 ā 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]