Between standard and practice: Comparison of DIN EN ISO 14155 with national legislation

Between standard and practice: Comparison of DIN EN ISO 14155 with national legislation

MEDIACC GmbH has submitted a request regarding the interpretation of certain aspects of DIN EN ISO 14155. This standard deals with clinical trials of medical devices on humans. After careful review and consultation with DIN experts, we are able to announce the following points:

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Terms and roles

The standard uses a number of terms that differ from the usual terms used in Germany in legal texts. This applies in particular to the roles and responsibilities of “clinical trial director”, “coordinating investigator”, “principal investigator” and “investigator” within clinical trials.

Practical implementation

In the practical conduct of clinical trials in Germany, these differences have not yet resulted in any significant problems. The competent ethics committees shall take into account the specific national requirements when evaluating them.

International cooperation

International studies often use different terms for senior examiners. In Germany, the role of “Head of Clinical Investigation” (LKP) remains the same, even though other titles are used internationally.

Continuous development

Standardization is a dynamic process. MEDIACC GmbH is closely following developments in this area and is in close contact with relevant experts and DIN and complies with the request to participate in the development of the new version of DIN EN ISO 14155.

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For detailed information on the interpretation of specific standard texts, we recommend that you contact the relevant DIN committee directly. We would also be happy to talk to you about this.