The organization should appoint experts and writers for developing a fully complied clinical evaluation report. The filled form helps us get more details about medical devices and manufacturers. Fill out separate forms for each device.

Manufacturer Name *

Address *

Address Line 1

Address Line 2

City

State / Province / Region

Postal Code

Country

Website / URL

Notified Body Selected / Interested?

Scope of Work (CER Writer / Consultant)

Dedicated team / Person to coordinate with consultants?

Yes
No
Will appoint Soon

Status of EU 2017/745 Technical Documentation

Name of the Medical Device *

Intended Use of the Device *

What is the purpose of this device?

Indications of Use

Medical conditions with which the device can be used for..

Intended Users *

Whom can make use of this device?

Target Population *

Who is ultimately getting clinically benefited upon using this device

Device Variants to be considered in the CER *

Number of Accessories part of the main device *

Name the accessories

Number of components part of the main device *

As per MDR accessories has to be considered in its own right.

Name the Components

Class of Device as per MDR *

Device Body Contact

Device Invasive action by

Submitter Name *

Designation / Job Title *

Phone *

Email *

REQUEST FOR PROPOSAL – CLINICAL EVALUATION REPORT DOCUMENTATION