CE Marking Prices (IVDR)

QMD Services provides conformity assessment under Regulation (EU) 2017/746 Annex IX and XI conformity routes for assessment of quality management systems (QMS) and technical documentation.  

QMD Services is determined to allow for transparency when it comes to its price policy. You have the ability to make an estimate of the charges for receiving and maintaining a CE Marking for your in-vitro diagnostic device. The prices are driven mainly by the regulatory risk classification of the device, the complexity and novelty of its 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 IVDR presents the risk-class dependent extent of conformity assessment and post-certification activities required by law.

The process includes an initial QMS audit followed by four surveillance audits and at least one unannounced audit over a five-year cycle. QMD will also conduct an extensive review and assessment of the technical documentation covering the entire range of IVD devices you are applying for a CE certificate(s), either by sampling or by reviewing all technical documentation depending on the risk classification.

Diagram 1 IVDR allows for estimation of the initial certification and surveillance costs based on the determined number of audit days and days for the technical documentation review. The number of days required are driven by the number of employees of your company, the product portfolio under assessment and risk classification of your IVD device(s) or device groups. In the second section of a routine 5-years cycle the costs of the re-certification and surveillance can be estimated.

Diagram 1 IVDR. Calculation of the initial and routine certification cycle costs based on number of employees and product portfolio under assessment and surveillance:

Table 2 IVDR details the minimum amount of work 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 IVDR for each type of activity required for your certification cycle is the minimum amount and the specific requirements of your company or device portfolio may require a higher number of days to assess your compliance to the regulation.

Table 2 IVDR. Minimum amount of audit days for a 5-year certification cycle (IVDR):