You must fill in the details requested to receive a precise MDR CE Marking service proposal. Based on the data entered below online, we determine the price and timeline. We are aware that this may be quite challenging for startup business owners and manufacturers, but we must have it to properly serve and support you! Do not forget to complete a separate form for each device you intend to CE mark .

Legal Manufacturer Name *

Address *

Address Line 1

Address Line 2

City

State / Province / Region

Postal Code

Country

Website / URL

Notified Body Selected / Interested? *

Scope of Manufacturer *

Scope of I3CGLOBAL *

Guidance & Technical Documentation
Guidance, Technical Documentation & Notified Body Coordination until CE Certification
Guidance, Technical Documentation, EU NB & CB Coordination until CE & UKCA Certification
Guidance, Technical Documentation and GSPR compliance for DDC Products

Product Expert to coordinate with I3CGLOBAL *

NIL
Yes
Will appoint if required.

ISO 13485 / QMS expert to coordinate with I3CGLOBAL *

Nil
Yes
Will appoint if required.

Medical Device Name *

Type of Device *

Device Risk Class as per MDR *

Intended use of the device *

What is the purpose of this device?

GMDN Code

Find GMDN Code from the below link. https://www.gmdnagency.org/account/login?ReturnUrl=/Terms/Search

EMDN Code

Find EMDN Code from the below link. https://webgate.ec.europa.eu/dyna2/emdn/

Brand Name / Trade Name

Number of Models / Varients

Device Body Contact *

Device Invasive Action *

Medical Device Use Condition *

Is the device Packed Sterile *

Yes
No

Is the device packed with accessories? *

Yes
No

Is the device packed with consumables? *

Yes
No

Is the device integrated with a software?? *

Yes
No

Is the device consisting of any nano particles? *

Yes
No

Is the device using any animal origin material? *

Yes
No

Is the device containing phthalate?? *

Yes
No

Is the device functions on power? *

Yes
No

Is the device connected with another device to function? *

Yes
No

Is the device using radiation? or waves? *

Yes
No

Submitter Name *

Job Title *

Phone *

Email *

MDR CE MARKING PROPOSAL REQUEST