Medical Device Market Approval & Certification

TÜV SÜD Danmark ApS MDR Conformity Assessment Procedures

Be confident of medical device market approval

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MDR 2017/745 APPLICATION PROCEDURE

TÜV SÜD has developed an online service registration form to allow us to systematically process your request. If you would like to request MDR services from TÜV SÜD, please use this form to register your interest.

Step-by-step information of the conformity assessment procedures of TÜV SÜD Denmark MHS highlighted below.

English is the only acceptable languages for the submission of documentation and any related correspondence.

The certification costs are based on hourly rates and take into account factors such as the size of company, number of sites, number and complexity of devices, etc. Standard fees are as follows:

Admin fee	EUR	DKK
Application administration fee	5,000	37,750
Annual maintenance fee, depends on company size	3,000 to 10,000	25,000 to 75,500
Initial Change notification review	320	2,500
Structured Dialogue, 1 hour	400	3,000

Audit and QM System Assessment Services	EUR, Hourly Rate	DKK, Hourly Rate
Audit¹	320	2,500
If technical assessor must participate in audit¹	430	3,300
Assessment of Change Notifications and Extensions related to QM Systems	320	2,500
¹The total audit cost includes all costs, incl. travel time, transport and accommodation.

Technical Documentation and Change Assessment Service	EUR, Hourly Rate	DKK, Hourly Rate
Technical Documentation Assessment	430	3,300
Assessment of Change Notifications and Extensions related to Technical Documentation	430	3,300