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MDR customer questionnaire / description / standard fees

MDR customer questionnaire / description / standard fees

Based on the product classification, the Manufacturers shall apply for the applicable conformity assessment procedure.

In order to prepare an offer for your company, we need a range of information. Please complete and send us the Customer questionnaire electronically (English or German are the only acceptable languages for the submission of documentation and any related correspondence).

Detailed information on each step of the conformity assessment process (applying relevant Annexes) is provided on our Description of the conformity assessment procedure according to Regulation (EU) 2017/745 and the QM system certification procedure EN ISO 13485.

The certification fees are based on current valid day rates (8 hours per day) reflecting factors such as the size of company, sites, number and complexity of devices, etc. Day rates may vary regionally. Please note that technical documentation assessment is also covering clinical evaluation biocompatibility, software and validations.

If you have any questions, please do not hesitate to contact us.

Conformity Assessment Activities

Dayrate

Application Review

2,950 €

Audit

2,100 €

Assessment of notified changes

2,950 €

Assessment of vigilance activities

2,950 €

Technical Documentation Assessment

2,950 €