BS EN ISO 14155:2020

What is ISO 14155 - Clinical investigation of medical devices about?  

ISO 14155 discusses the clinical investigation of medical devices for human subjects. ISO 14155 outlines good clinical practice for the design, conduct, recording, and reporting of clinical investigations carried out in human subjects to assess the clinical performance or effectiveness and safety of medical devices. 

ISO 14155 specifies general requirements intended to define the responsibilities of the sponsor and principal investigator, and assist sponsors, investigators, ethics committees, regulatory authorities, and other bodies involved in the conformity assessment of medical devices. 

Note: ISO 14155 does not apply to in vitro diagnostic medical devices. However, there can be situations, dependent on the device and national or regional requirements, where users of this document might consider whether specific sections and/or requirements of this document could be applicable. 

Who is ISO 14155 - Clinical investigation of medical devices for? 

ISO 14155 on the clinical investigation of medical devices is useful for: 

• Clinicians conducting clinical trials with medical devices 
• Clinical research professionals (e.g. clinical research associates, clinical project managers) 
• Medical device manufacturers sponsoring clinical trials 
• Regulatory bodies (regulatory agencies, Notified Bodies) 
• Ethics committees 
• Clinical research organizations 

Why should you use ISO 14155 - Clinical investigation of medical devices? 

ISO 14155 deals with good clinical practice for the design, conduct, recording and reporting of clinical investigations carried out on human subjects to assess the safety or performance of medical devices for regulatory purposes. ISO 14155 provides a way to verify the quality and fitness for purpose of clinical data obtained for regulatory purposes. 

The principles set out in ISO 14155 also apply to all other clinical investigations and should be followed as far as possible, considering the nature of the clinical investigation and the requirements of national regulations. 

ISO 14155 specifies general requirements intended to: 

• Protect the rights, safety and well-being of human subjects 
• Ensure the scientific conduct of the clinical investigation and the credibility of the clinical investigation results 
• Define the responsibilities of the sponsor and principal investigator 
• Assist sponsors, investigators, ethics committees, regulatory authorities and other bodies involved in the conformity assessment of medical devices 

ISO 14155 includes clarifications and expansions that will ensure greater compliance with regulatory requirements. These will better meet user needs, improve patient safety, speed up the route to market and provide greater confidence in the regulatory compliance of marketed products. 

What’s changed since the last update? 

ISO 14155:2020 supersedes ISO 14155:2011, which has been withdrawn. BS EN ISO 14155:2020 has some technical changes with respect to ISO 14155:2011. These include: 

• Inclusion of a summary section of GCP principles (see Clause 4) 
• Reference to the registration of the clinical investigation in a publicly accessible database (see 5.4) 
• Inclusion of clinical quality management (see 9.1), risk-based monitoring (see 6.7), statistical considerations in Annex A, and guidance for ethics committees in Annex G 
• Reinforcement of risk management throughout the process of a clinical investigation (planning to consideration of results) including Annex H 
• Clarification of applicability of the requirements of this document to the different clinical development stages (see Annex I) 
• Inclusion of guidance on clinical investigation audits (see Annex J)