NSAI has published I.S. EN ISO 14155: 2020 - "Clinical investigation of medical devices for human subjects – Good clinical practice", which supersedes the 2011 version of the Standard. The document was prepared by the International Standards Technical Committee 194 (ISO TC 194) in conjunction with the European Committee for Standardization Technical committee 206 (CEN TC 206) under the Vienna Agreement between ISO and CEN (Agreement on technical co-operation). Both Technical Committees develop Standards for the biological and clinical evaluation of medical devices.
The scope of the Standard addresses 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.
The main changes in the new edition are as follows:
- inclusion of a summary section of Good Clinical Practice principles (Clause 4);
- reference to registration of the clinical investigation in a publicly accessible database (per subclause 5.4);
- inclusion of clinical quality management (per subclause 9.1);
- inclusion of risk-based monitoring (per sub-clause 6.7);
- inclusion of statistical considerations in Annex A (normative);
- inclusion of guidance for ethics committees in Annex G (informative);
- reinforcement of risk management throughout the process of a clinical investigation including guidance on the application of IS0 14971 to clinical investigations set out in Annex H (informative);
- clarification of applicability of the requirements of the standard to the different clinical development stages in Annex I (Informative);
- inclusion of guidance on clinical investigation audits in Annex J (Informative).
The Standard includes Annex ZA and ZB that demonstrate the relationship with both the Medical Device Directive and the Active Implantable Directive. While the new version is not currently listed in the European Commission's mandate to CEN to develop Standards supporting the Medical Device Regulation, it is expected the list will be updated to include the latest version.
NSAI Notified Body Clinical Reviewers welcomed the publication of this new version of the Standard which reflects the current "State of the Art" for the evaluation of clinical investigations.
They stated: "The expansion of current definitions and topics will provide the clarity and detail needed to ensure that an effective clinical investigation has been performed to support the safety and performance of medical devices. The introduction of new information, covering topics such as good clinical practice principles, risk management, and clinical investigation audits, will provide additional resources and requirements for manufacturers to include as part of their clinical evaluation and technical file submission."
Manufacturers should begin carry out a gap analysis between the ‘state of the art’ standard (the latest published version) and the previous version and plan the transition to this new version of the standard for future clinical studies. It is advisable to contact your Notified Body to discuss and review transition plans for the use of this new clinical study standard.
The standard is available here.