Clinical Evaluation Report (CER) and Plan (CEP) Templates – 10% off

Description

This is a complete package that includes the 2 essential document templates for an EU MDR 2017/745-compliant Notified Body (NB) submission:

• Clinical Evaluation Report (CER)
• Clinical Evaluation Plan (CEP)

The Clinical Evaluation Report (CER) Template is specifically designed to be used in conjunction with the Clinical Evaluation Plan (CEP) Template.

The sections of this CER Template include all the fundamental components of an EU MDR 2017/745-compliant CER. Moreover, the structure and sections as well as their order and content follow the MEDDEV 2.7/1 Rev. 4 guidelines and Medical Device Coordination Group (MDCG) 2020‑6 and MDCG 2020‑13 recommendations conforming to the expectations by the Notified Body (NB).

The Clinical Evaluation Plan (CEP) Template is specifically designed to be used in conjunction with the Clinical Evaluation Report (CER) Template, and intended for straightforward transfer of information from the CEP into the CER.

The sections of this CEP Template include all the fundamental components of an EU MDR 2017/745-compliant CEP. The structure and sections as well as their order and content follow the MEDDEV 2.7/1 Rev. 4 guidelines and Medical Device Coordination Group (MDCG) 2020‑6 recommendations conforming to the expectations by the Notified Body (NB). This enables content of the finalized CEP to be directly copied into the equivalent sections of the associated CER Template, with only minor modifications to the tense as instructed throughout.