At the end of January, the European Commission published the newest list of standards harmonised with the Medical Device Regulation (MDR) 2017/745. Commission Implementing Decision (EU) 2026/193 details twelve international standards in a continued effort to provide manufacturers of medical devices with more clarity on how best to conform with MDR requirements. A notable inclusion in the list is ISO 14155:2020 Clinical investigation of medical devices for human subjects — Good clinical practice.
ISO 14155 has long been the globally-recognised standard for good clinical practice (GCP) in medical device clinical investigations. Previously harmonised with the Medical Device Directive (MDD) 93/42/EEC, it is widely used by manufacturers and research organisations worldwide seeking to verify the clinical benefits of medical devices.
The standard provides a comprehensive framework for designing, conducting, recording, and reporting clinical studies involving human subjects. Central to the standard are:
- Ethical principles consistent with the Declaration of Helsinki
- Responsibilities for sponsors and investigators
- Requirements for study design and documentation
- Integration of risk management throughout the investigation
- Protection of subjects’ rights, safety and well‑being
- Assurance of data integrity and scientific validity
In the MDR, requirements for clinical investigation are laid down in Annex XV. They include ethical oversight, scientific justification, safety reporting and data management. These provisions aim to ensure that clinical evidence supporting device conformity is robust, transparent and ethically sound. The clinical investigation forms a crucial part of the broader clinical evaluation in which safety and performance of the medical device are demonstrated and the benefit-risk profile is established.
Through the amendment EN ISO 14155:2020/A11:2024, this standard has now been given formal presumption of conformity with the specific MDR requirements on clinical investigations. The result is strengthened alignment between global GCP principles and the EU’s stricter clinical evidence framework.
Harmonisation of ISO 14155:2020 with the MDR closes the gap between implementing the standard as best practice and as a means for achieving conformity with MDR Annex XV. It is imperative that manufacturers and sponsors ensure that clinical investigation procedures reflect the harmonised requirements.
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