MDR pre application phase

Application Phase

Technical Documentation within the MDR conformity assessment procedure

Technical Documentation within the MDR conformity assessment procedure


In the case of modification of a certified product, the process starts with the change related to MDR Technical Documentation application phase.

A quotation for the review process is prepared based on and tailored to the contents of the application to be assessed. After an independent review of the application with a positive result, the assessment of the MDR technical documentation can be started. A positive result of the review and the independent certification decision enables the issuance of a revision of the related certificate.

Download documentation checklists for structured data assessment.

The timelines given are target timelines from the planning model. Individual timelines may differ.


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