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New drug/device borderline guideline due out any day now, says Commission

This article was originally published in Clinica

Executive Summary

The European Commission told Clinica on June 22 that it is finalising the revised drug/device borderline guideline, meddev 2.1.3, and that this document should be published by the end of June. This is a complex area and given the rapid technological evolution in this area, there is much need for this update. The last guideline to be published by the Commission, 16 pages long, is dated July 2001.

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