QMD Services conducts conformity assessments under Regulation (EU) 2017/745 according to Annex IX (conformity assessment based on a Quality Management System and on assessment of technical documentation) as well as Annex XI, Part A (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 medical 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 medical device lifecycle.
Table 1: Conformity assessment and surveillance for medical devices according to Regulation (EU) 2017/745 (MDR)
For the process of CE-certification and the surveillance period QMD will conduct reviews and assessments of the technical documentation covering the entire range of devices you are applying for. This will be either by sampling or by reviewing your technical documentations depending on the risk classification. The process will include an initial QMS audit followed by four surveillance audits and at least one unannounced audit over a five-year cycle.
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 per certification cycle is the minimum requirement, 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 (MDR)
The rates for QMD Services as of 14. May 2024 can be found in the download section below.
