Name: Clinical Evaluation MDR Pack (CEP + CER)
SKU: EMD-015-EMD-016-EMD-017
Price: 127.00 EUR
Availability: InStock

Clinical Evaluation MDR Pack (CEP + CER)

127,00€

CLINICAL PACK with 5 documents

Clinical Evaluation Plan Template
Clinical Evaluation Report Template
Literature Search Report
Product Equivalence Table Template (MDCG 2020-5)
CER Checklist Template (MDCG 2020-13)

These documents are in Word format and can be edited.

After purchase, these products cannot be refunded.

SKU: EMD-015-EMD-016-EMD-017 Category: MDR 2017/745

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.