The GHTF releases a new version of the document from the previous year:
GHTF SG5 – Clinical Evaluation – May 2007.
The document has a similar structure to MEDDEV 2.7.1 Guideline from 2003, but it goes beyond in some points.
The requirements draw on the demands of the GHTF linked with the other Study Groups with the aim of international standardization of methods in terms of
clinical evaluations and clinical studies.
In addition to the documents concerning clinical evaluations the Study Group 5 releases also a document containing definitions of clinical data:
GHTF SG5 – Clinical Evidence – Key Definitions and Concepts