Definition and clinical trial purpose

Clinical trial: Any systematic investigation involving one or more human subjects to evaluate the safety or performance of a device.
• Clinical investigations of medical devices are usually conducted as a result of regulatory requirements
• The purpose of conducting a clinical investigation should be agreed at the beginning of the planning process, as it will have a direct impact on the design of the study and the clinical data that needs to be generated.

The relationship between clinical trials and the life cycle of medical products

• Design - verification - confirmation - production - sales - after sales
• According to quality management system ISO13485
• Design validation should be performed on representative products
• Representative products include initial production units, batches, or equivalent products
• As part of the design and development validation, the organization shall conduct a clinical evaluation or performance evaluation of the medical device in accordance with applicable regulatory requirements
• Medical devices used for clinical evaluation or performance evaluation are not considered to be released to customers for use 

Clinical trials can be divided into three stages: planning, execution and completion

Clinical trial planning

1、Planning considerations
• Medical device regulations
• In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (EU IVDR)
• Medical device regulations（EU）2017/745（EU MDR）

2、Quality management system requirements
• Regulatory requirements (International -MDSAP, Regional -MDR, National - US FDA, Canada -HC, etc.)

3、Guidance document
• ISO 14155-2020 Clinical Studies of medical devices in human subjects - Good clinical trial practice
• MEDDEV 2.7/4 on the necessity and general principles of clinical research
• MEDDEV 2.7/2 Rev 2 on clinical investigation validation and competent authority evaluation
• MDCG 2021-20 Instructions for generating CIV-ids for MDR clinical studies
• MDCG 2021-08 Clinical Study Application/Notification document
• ISO 20916:2019- In vitro diagnostic medical devices - Clinical performance studies using human samples - Good research practice
• MDCG 2021-2- Updated Technical Guidance for rapid Antibody testing for COVID-19

4、staffing

5、Compile clinical investigation files

6、Site selection

7、Establish trial termination procedures


Clinical trial execution

1、Clinical trial operating procedure standard
2、Approval by relevant departments
3、monitor