Be confident of IVD medical device market approval
Thank you for your interest in registering for a service with TÜV SÜD. Please complete the Manufacturer Data List file and submit the completed file to [email protected].
Please ensure you include the following information in your email:
This will enable you to have an early registration for one of our specific IVDR services. You will receive further updates regarding your requests within the next weeks.
Please note that the submission of this form is not a pre-application or application for IVDR services. It also does not guarantee an application acceptance by TÜV SÜD. TÜV SÜD is currently in a transition phase where we are shifting and preparing our systems and resources to provide services under the new legislative framework. We have had and continue to clarify open questions and implement newly published information about the IVDR into our processes.
For any enquiries, please contact us at [email protected].
Thank you and look forward to hearing from you!
An overview on how to submit a Technical Documentation
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Bosnia and Herzegovina