EN ISO 14155:2020 /A 11:2024 — Clinical Investigations of Medical Devices and Good Clinical Practice (GCP)

The European standard EN ISO 14155:2020 /A 11:2024, (March 2025), which deals with clinical investigations of medical devices on humans and good clinical practice (GCP), modifies EN ISO 14155:2020 with the aim of providing a harmonised framework for carrying out clinical investigations (medical device clinical trials) in Europe, which enables compliance with Regulation (EU) 2017/745 on medical devices (MDR), in particular the requirements of the Annex XV of the MDR relating to clinical investigations.

DIN EN ISO 14155/A11 ensures that clinical studies involving medical devices are carried out safely, ethically and in accordance with EU requirements (MDR).

Key content areas

The standard covers various aspects of clinical studies of medical devices, including:

• Terminology: Deviations from the definitions of ISO14155 and MDR are listed. National deviations from the scope of application may have to be considered with regard to MDR. Slight deviations were identified for the terms: adverse event, clinical investigation plan, clinical performance, product deficiency, ethics committee, informed consent, investigational device, medical device, serious adverse event, sponsor and study participant. There are differences between: investigator and serious health threat.
• Relationship between EN ISO 14155 and MDR: References, in particular to Annex XV of the MDR, are listed insofar as they relate to clinical investigations.

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Please check the current list in the EU Official Journal regularly to ensure that these statements remain applicable. Additional EU rules may apply to products covered by this standard.

If you are interested in clinical trials for approval or reimbursement purposes in compliance with current standards and requirements, please feel free to arrange a first, non-binding consultation with us. We're here for you!

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