MEDDEV 2.7.1 Rev 4 – Demystifying the new requirements
MEDDEV 2.7.1 Rev 4 – Demystifying the new requirements MEDDEV 2.7/1 is a guiding document for clinical evaluation of medical devices and it is titled as “Clinical Evaluation: A Guide for Manufacturers and Notified Bodies under Directives 93/42/EEC and 90/385/EEC”. MEDDEV 2.7/1 revision 04 (guideline for clinical evaluations) is available for guidance since 1st July 2016. […]