CE MARKING COST ESTIMATE (IVDR)

QMD Services conducts conformity assessments under Regulation (EU) 2017/746 according to Annex IX (conformity assessment based on a Quality Management System and on assessment of technical documentation) as well as Annex XI (conformity assessment based on production quality assurance). 

QMD Services is committed to provide a transparent price policy in order for you to facilitate budgeting. Please find below an overview of the charges for receiving and maintaining a CE Marking for your in-vitro diagnostic device. The costs are calculated individually and based on the number of devices, the regulatory risk classification of the device, the complexity and novelty of the technology, the risks associated with the intended use of the device, the complexity of the manufacturing technologies, and the required degree of vigilance and post-market surveillance activities throughout the IVD device lifecycle.

Table 1 illustrates the risk-class nature of conformity assessment and post-certification activities required by the regulation for a five years period.

Table 1 Conformity assessment and surveillance for in-vitro diagnostics acc. Regulation (EU) 2017/746 (IVDR)

 

The process including the CE-Certification and the surveillance period starts with an initial QMS audit followed by four surveillance audits and at least one unannounced audit over a five-year cycle. QMD will also conduct reviews and assessments of the technical documentation covering the entire range of IVD devices you are applying for, either by sampling or by reviewing all technical documentation depending on the risk classification.

Table 2 details the minimum amount of working days to be expected for each type of service, linked to the notified body activities required by the Regulation. Please note that the number of days given in Table 2 for each type of activity required for your certification cycle is the minimum amount required, your company or device portfolio may require a higher number of days to assess your compliance to the Regulation.

Table 2 Minimum Amount of Assessment Days for a Five Year Certification Cycle (IVDR)

The rates as of January, 1st 2023 for the services of QMD Services are as follows:

Table 3 Rates for the services of QMD Services (all fees are exclusive VAT)

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