If you are a manufacturer and you want to place your medical device on the EU market, you need to make sure it complies with the specific European Directives set forth by the European Commission. In that case, of importance are the Medical Device Directives (MDD): AIMDD 90/385/EEC; MDD 93/42/EEC; IVDMDD 98/79/EC. To proof that your device complies with the essential requirements of these CE directives, you need to affix a CE mark to it. For that purpose, your product needs to go through the CE marking process. The direction of the latter depends on the class of your medical device and your choice of a conformity assessment route. Specific characteristics of your medical device will determine its class, and respectively how risky it is for the patients. For instance, characteristics such as intended use, invasiveness, and local vs. systemic effects.
According to the European framework, there are four classes of medical devices: Class I, IIa, IIb and III. The medical devices of Class III hold the highest risk. Today, due to the stricter rules of the new Regulation system, the class of many devices changed. Before they would’ve been placed in class IIa or IIb, but now they will be in class III. If your medical device is in any other class apart from class I, you will have to provide the Notified body with a proof that your product fulfills the essential requirements of the respective CE directives. Keep reading to learn more about each class and what steps you will need to pass to CE mark your product .