What is Medical Device CE Marking and CE Certification?
The Difference Between CE Marking and CE Certification
Under the 93/42/EEC Medical Device Directive (MDD), medical devices are classified into risk categories based on their intended use, locations of use, usage duration, and product content, with classifications such as Class I, Class Is, Class Im, Class IIa, Class IIb, and Class III.
Similarly, the 2017/745/EEC Medical Device Regulation (MDR) also classifies medical devices into risk categories, including Class I, Class Is, Class Im, Class Ir, Class IIa, Class IIb, and Class III.
In both regulations, Class I medical devices are subject to CE Marking, while other classes (Class IIa, Class IIb, and Class III) undergo the CE Certification process.
CE Marking
The responsibility during the process lies entirely with the manufacturer and the Medical Device Manufacturer obtains the right to affix the CE marking to their products by preparing their Technical Files together with the necessary studies in accordance with the ISO 13485 Quality Management System establishment and the relevant directive/regulation.
CE Certification
In the processes, a CE Certification process is carried out based on the conformity of all relevant work carried out with the documentation audits to be carried out by the Notified Body, both in the field and in relation to the work carried out, by the Notified Body, taking responsibility together with the Medical Device Manufacturer.