European Medical Device Regulation
2017/745 & Clinical Evaluation Reports (CER)
GMED North America designed a comprehensive 3-day training course for the preparation and application framework surrounding CE marking under the EU MDR 2017/745, to help Medical Device companies understand the expectations of the new Regulation, including those pertaining to the Clinical Data Requirements and their implications on Clinical Evaluation Reports (CERs).
Assess the impacts of those changes on their organizational and structural activities
Understand the Product Classification criteria’s and Conformity Assessment routes and how it applies to their device(s);
Address the Quality Management System (QMS) requirements;
Assess the impacts on the Technical Documentation for Medical Devices in relation with Product Classification criteria’s and Conformity Assessment routes;
Identify the expectations with respect to the Clinical Evaluation, Clinical Data(s) and Risk Management, including Post- Market Clinical Follow- Up;
Implement the requirements for labeling, the Unique Device Identification (UDI) and EUDAMED;
Understand the expectations for Clinical Investigation Requirements & “sufficient” clinical data(s);
Address the requirements pertaining to Vigilance and Post- Market Surveillance Requirements (PMS), including Periodic Safety Update Report (PSUR);
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