Clinical Evaluation Report Between Class I and Class IIa

[Angsp]

Would like to know what is the difference between Class I and Class IIa CER report.
Currently working on sterile powder free glove and was looking for CER writer.
Company would like to know what is the different between these 2 classes.
I am newly joined the team have no knowledge about regulatory.

Kindly need helps from the experts. Many thanks.

 

[Apoorva]

CER report structure is based on MDCG guidance irrespective of the Class of the product. Structure of report is same for all types of products but the sub sections will be vary. There is a pdf available for MDCG 2020-13 CER report for any class of Medical Device. Please check it once.

 

[Angsp]

Thanks Apoorva.