Update to EU’s Medical Device Clinical Evaluation Guidelines

In June, the European Commission released Revision 4 of MEDDEV 2.7/1 Clinical Evaluation: A Guide for Manufacturers and Notified Bodies, found amidst other guidance documents here. The release constitutes a major re-write of the previously issued guidance (found here), increasing the document from 46 to 65 pages of "how-to" conduct the Clinical Evaluation. Though not legally binding

By | 2017-08-08T21:55:54+00:00 July 6th, 2016|Compliance Updates & Legal Info|