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IVDR Request for Service Registration

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

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IVDR Technical Documentation

IVDR TECHNICAL DOCUMENTATION SUBMISSION REQUIREMENTS

An overview on how to submit a Technical Documentation

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ADDRESSING CHALLENGES IN PHARMA MANUFACTURING THROUGH INDUSTRY 4.0

IVDR CERTIFICATION PROCESS

The Process from A - Z according to Annex IX

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sampling

SAMPLING OF CLASS B AND C IVDR DEVICES

Sampling for Assessment of Technical Documentations according to IVDR Annex IX

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Next Steps

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