MDR and IVDR CE Marking Services

In order to sell your medical devices in Europe, they must first be CE Marked. CE Marking is Europe’s version of marketing approval.
Prior to CE Marking a medical device, manufacturers must compile technical and clinical documentation to demonstrate compliance with the EU Medical Device Regulation (MDR) 2017/745.
Furthermore, unless the device is the very lowest risk class, it must undergo a conformity assessment review by a Notified Body. Notified Bodies are organizations accredited and supervised by the European National Competent Authorities, and their role is to evaluate if products have met the minimum safety and efficacy requirements. The Notified Body issues “CE Mark Approval” for the device by issuing a CE certificate.
If the device is the lowest risk, then it does not require a CE certificate issued by a Notified Body. Instead, the manufacturer must compile with the safety and efficacy requirements, and then they will “self-certify” the device. They will affix the CE symbol on their product and sign a Declaration of Conformity, which is a legal document, asserting that they have met the minimum requirements of the regulation.
Below we have broken down each element of the technical file documentation. Smart QARA Consulting takes a practical, business minded approach to assisting manufacturers achieve CE marking. We are available to work with you for elements of your technical documentation or for full support.