How to use ISO 13485 to get your devices approved for CE Marking?
The CE marking is a gateway to marketing products in Europe, even if the medical device was produced somewhere other than the European Union. It is the producer’s mandatory obligation to acquire and display the CE mark on the device before marketing it in the European Economic Area (EEA). If the medical device is imported from outside the EEA, then this obligation transfers to the importer. The term “CE” is the short form of the French phrase “Conformité Européene,” which translates to “European Conformity” in English. ISO 13485 is aligned with European medical device directives; therefore, its implementation helps to fulfill the requirements of these directives. Three different directives are applicable to different types of medical devices in Europe. Both the Medical Device Directive (93/42/EEC) and the Active Implantable Medical Devices Directive (90/385/EEC) have been modified by a new directive (2007/47/CE). The third directive is the In Vitro Diagnostics Directive (98/79/EC).