Definition & Purposes of Clinical Trials
Definition of Clinical Trial：Any systematic investigation involving one or more human subjects to evaluate the safety or performance of a medical device.
- Medical device clinical investigations are generally conducted to meet regulatory mandates.
- The objectives of a clinical investigation shall be agreed upon at the outset of planning, as they exert a direct impact on study design and the clinical data to be generated.
Link Between Clinical Trials and the Full Lifecycle of Medical Products
The full lifecycle of a medical product covers: Design – Verification – Validation – Production – Distribution – Post-market Surveillance
- Applicable quality management system standard: ISO 13485
- Design verification shall be performed on representative products
- Representative products include initial production units, batches or equivalent items
- As part of design and development verification, organizations shall conduct clinical evaluation or performance evaluation of medical devices in accordance with applicable regulatory requirements
- Medical devices used for clinical or performance evaluation are not deemed released for customer use
Clinical trials are divided into three phases: Planning – Execution – Closure
Clinical Trial Planning
1.Planning Considerations
- Medical device regulatory requirements
- EU Regulation 2017/746 on In Vitro Diagnostic Medical Devices (EU IVDR)
- EU Regulation 2017/745 on Medical Devices (EU MDR)
2.Quality Management System Requirements
Compliance with a full spectrum of regulatory requirements, including international standards such as MDSAP, regional regulations including MDR, and national authorities’ rules such as US FDA and Health Canada (HC).
3.Guidance Documents
- ISO 14155:2020 Clinical investigation of medical devices for human subjects – Good clinical practice
- MEDDEV 2.7/4 Guidance on the necessity and general principles of clinical investigations
- MEDDEV 2.7/2 Rev 2 Clinical investigation verification and assessment by competent authorities
- MDCG 2021-20 Guidance on generating CIV-IDs for clinical investigations under MDR
- MDCG 2021-08 Documentation for clinical investigation applications / notifications
- ISO 20916:2019 In vitro diagnostic medical devices – Clinical performance studies using human specimens – Good study practice
- MDCG 2021-2 Updated technical guidance on COVID-19 rapid antibody tests
4.Staffing Arrangement
5.Compilation of Clinical Investigation Dossiers
6.Site Selection
7.Establishment of Trial Termination Procedures
Clinical Trial Execution
- Standard Operating Procedures (SOPs) for clinical trials
- Approvals from relevant authorities / departments
- Clinical Monitoring
