The new edition of the ISO 14155 reinforces the principles of good clinical practices (GCP) in clinical investigations with medical devices. While the principles were defined earlier and belong to the state of the art in research involving human beings, the new ISO 14155 specifies further elements and embed them into requirements according to MDR. A special focus is on risk management during the clinical investigation process, where a tight relationship to ISO 14971 is described.
Helpful is the clarification of applicability of the requirements of the new ISO 14155 to the different clinical development stages in line with recent MDCG guidelines and MDR.
The third edition cancels and replaces the second edition (ISO 14155:2011), which has been technically revised. The major changes to the previous edition are as follows:
- inclusion of a summary section of GCP principles (see Clause 4);
- reference to registration of the clinical investigation in a publicly accessible database (see 5.4);
- inclusion of clinical quality management (see 9.1);
- inclusion of risk-based monitoring (see 6.7);
- inclusion of statistical considerations in Annex A;
- inclusion of 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).
Adhering to the new edition of ISO14155 is a prerequisite for acceptance of clinical data in safety and performance assessments of medical devices in EU and foreign regions.