IVDR CE MARKING PROPOSAL REQUEST

You must fill in the details requested to receive a precise IVDR CE Marking service proposal. Based on the data entered below, we determine the price and timeline. We know this may be challenging for start-ups and manufacturers, but we need it to properly serve and support you. Please complete a separate form for each device you intend to CE mark.

1. Manufacturer & Contact

2. Device Information

3. Scope & Characteristics

Manufacturer Information

Legal Manufacturer Name *

This field is required.

Address Line 1 *

This field is required.

Address Line 2

City *

This field is required.

State / Province / Region *

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Postal Code *

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Country *

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Website / URL

Submitter / Contact Person

Submitter Name *

This field is required.

Designation / Job Title *

This field is required.

Phone *

Please enter a valid phone number.

Email *

Please enter a valid email address.

Device Information

In Vitro Device Name *

This field is required.

Brand Name / Trade Name

Type of Device

Device Risk Class as per IVDR *

This field is required.

Intended Use of the Device *

This field is required.

IVDR Code *

This field is required.

GMDN Code

EMDN Code

Number of Models / Variants

Device Usage

Certification Scope

Notified Body Selected / Interested?

This field is required.

Scope of Manufacturer *

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Scope of MedDeviceCorp *

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Product Expert *

No product expert currentlyYes, we have a product technical expertWill appoint if required

Please select an option.

ISO 13485 / QMS Expert *

No QMS / ISO 13485 expert currentlyYes, we have a QMS / ISO 13485 expertWill appoint if required

Please select an option.

Device Characteristics *

Does the device…	Yes	No

Please answer all device characteristic questions.

Thank you! Your request has been received.

Our IVDR team will review the details and send your CE Marking proposal shortly. A copy of your request has been emailed to you.