Price list on standard fees

EU - Medical Device Regulation 2017/745 (MDR)

The costs for a conformity assessment procedure according to MDR, are calculated individually on an hourly basis, taking into account the size of the company, number of locations and complexity of the products.

The hourly rates for the services of DQS Medizinprodukte GmbH are as follows, plus the statutory VAT:

Specifications Hourly rate
General activities in the context of the conformity assessment procedure250,00 €
Audit activities250,00 €
Performance of unannounced audits250,00 €
Examination of technical documentation250,00 €
Processing of change notifications and re-evaluations250,00 €
Review of the Periodic Safety Update Report (PSUR, SSCP) and the clinical evaluation250,00 €
Involvement of external experts (e.g. clinical expert)375,00 €
Travel time100,00 €