As outlined in the MDR, the rules regarding clinical investigations should align with established international guidance, such as ISO 14155:2011, which addresses good clinical practice for clinical investigations of medical devices involving human subjects. The new edition of this standard was released in 2020 providing updated guidelines for the design and conduct of clinical investigations for medical devices. However, it is important to note that ISO 14155:2020 is not recognized as a harmonized standard under the MDR.
While both ISO 14155:2020 and the MDR text outline many procedural and documentation requirements for clinical investigations, they may sometimes present differing requirements. Additionally, the Medical Device Coordination Group (MDCG) offers guidelines addressing a variety of questions related to clinical investigations under MDR. Thus, manufacturers must pay close attention to how they conduct various procedural aspects and prepare the necessary documentation to ensure compliance of their clinical investigations.
According to ISO 14155:2020, it is essential to consider whether other standards or national requirements apply to the investigational devices or the clinical investigation. If differences in requirements exist, the most stringent apply. The MDCG 2024-3 document further explains that adherence to ISO 14155:2020 is strongly recommended, as it serves as a valuable resource for sponsors planning and developing their clinical investigations, although it is not mandatory for investigations conducted under the MDR. For example, when preparing the Clinical Investigation Plan, sponsors are encouraged to review both the MDR and ISO 14155:2020. If discrepancies arise between the MDR and the standard, the legal requirements of the MDR take precedence.
Nevertheless, while the use of standards is voluntary, compliance with ISO 14155:2020 serves as a means for demonstrating conformity with regulatory requirements for clinical investigations of medical devices in many countries around the world when it is accepted, ensuring the protection of human subjects and the scientific validity of the study results. Also, ISO 14155:2020 is a valuable resource for information on the various development stages and related clinical investigation designs for investigational medical devices, as extensively outlined in Annex I.
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