On this pack, you will find 5 documents which are templates for the creation of your Clinical Evaluation Plan and Reports and MDCG template documents to help you fulfill the EU MDR requirements..
The Clinical Evaluation Plan is now a separate document when before it was allowed to be included with the CER. So these documents are following the requirements of EU MDR 2017/745 and MEDDEV 2.7/1 Rev 4.
Warning: These documents are only templates and are not adapted to all the type of products that you should evaluate. So you can completely review its content. Easy Medical Device provides also some support for Clinical Evaluation Document creation in the case you think you are not able to complete this alone.
See below the table of content of those documents.