Building a Quality PMCF Report

Building a Quality PMCF Report
The EU has introduced new Regulation (EU) MDR 2017/745 providing new requirements for Post Market Clinical Follow up (PMCF). In this white paper we will discuss the requirements for preparing a PMCF plan and report according to Regulation (EU) 2017/745, MEDDEV 2.12/2 REV 2 MEDDEV 2.12/1 REV 8 and MEDDEV 2.7/1 REV 4