The CE Mark and approval under the European Commission’s Medical Devices Regulation is the key to opening the European market for medical devices. While Notified Bodies are the key for higher level medical devices, Class 1 devices can receive the CE Mark via creation of a registration dossier that complies with the EN standards that govern the CE Mark for medical devices by Israeli, US, and other non-European companies as well.Requirements include:
1. Safety Testing Data.
To self-register under the CE Mark, safety data is required. This should be generated based on EU standards governing safety for medical devices.
2. Efficacy Testing Data.
2.If claims of efficacy are made for the medical device, the CE Mark standards also specify what kinds of testing are required.