IVDR Request for Service Registration

Be confident of IVD medical device market approval

Be confident of IVD medical device market approval

Thank you for your interest in registering for a service with TÜV SÜD. Please follow the 3 simple steps below for an early registration for one of our specific IVDR services:

  • Download and fill in the Manufacturer Data List file.
  • Complete the applicable sections of the form below and upload the completed Manufacturer Data List file.
  • Submit your request.

You will receive further updates regarding your requests within the next weeks.

Download the Manufacturer Data List here

1. FILE SUBMISSION

Please upload the completed Manufacturer Data List file here

Please note that the submission of this form is not a pre-application or application for IVDR services. Please bear in mind that complete information is very important for faster processing.

For any enquiries, please contact us at [email protected]

Other than IVDR services, TÜV SÜD also offers medical devices testing services. Please refer to 4. Additional services related to Product Testing of the registration page.

2. COMPANY INFORMATION

Please provide your company details:

Please provide your:*

3. TYPE OF REQUEST

4. ADDITIONAL SERVICES RELATED TO PRODUCT TESTING

The below listed Testing Services provided by TÜV SÜD are not directly part of the EU Conformity Assessment. However, resulting test reports may be used to complete the Technical Documentation of the manufacturer in order to show compliance with international standards and product specific requirements of the regulations.

Please only click the submit button once. The submit button will turn grey when the system is registering your request. A delay of up to 60 seconds may be experienced after clicking submit. Thank you for your patience while we work to improve this form.

I may withdraw my consent at any time with future effect. For further details, refer to the privacy statement. For more information about TÜV SÜD and its affiliates, refer to list of TÜV SÜD affiliates.

If you encounter any issues when submitting this form, please email [email protected] for assistance.

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