Pre-Application Phase

Technical Documentation within the MDR conformity assessment procedure

Technical Documentation within the MDR conformity assessment procedure

PRE-APPLICATON PHASE

In the MDR technical documentation (pre-)application phase for EU MDR Technical Documentation, an application for certification is sent to TÜV SÜD and negotiated between the Notified Body (TÜV SÜD) and the manufacturer. Submission of the data triggers the quotation process and initiates the application phase, including the application review to ensure regulatory compliance and the feasibility of certification.

Download documentation checklists for structured data assessment.

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

MDR
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The EU’s Medical Device Regulation

Staying up-to-date with the new requirements

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Medical and healthcare services
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Mhs technical document
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TÜV SÜD Technical Documentation

According to the Medical Device Regulation (EU) 2017/745 (MDR)

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