A new version of ISO 14155 has been published — what does it mean for medical device clinical investigations?
ISO 14155 is the leading standard for Good Clinical Practice (GCP) in medical device clinical investigations and remains highly relevant for manufacturers operating under Regulation (EU) 2017/745 (MDR).
Even from an initial review of the updated abstract, several points are already worth noting:
• A broader focus on protecting not only human subjects, but also users or other persons;
• Continued applicability to post-market clinical investigations;
• Ongoing recognition of the particular considerations associated with Software as a Medical Device (SaMD).
These developments may be particularly relevant for manufacturers reviewing their clinical development plans, PMCF activities, or overall clinical evidence strategy.
At the same time, one important regulatory point should not be overlooked: the version that currently provides presumption of conformity with the MDR is still the harmonised standard EN ISO 14155:2020.
The publication of a new ISO edition is therefore an important signal for the sector, but it does not automatically change the harmonised framework applicable in the EU.
For manufacturers planning clinical investigations or reassessing their clinical strategy under the MDR, now is a valuable moment to understand how this update could affect future expectations and documentation.
To read the complete document, you can access it here: https://www.iso.org/standard/83968.html
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