Regulatory Compliance: Certification confirms that the device complies with EU regulations and standards for medical devices, ensuring it is safe and effective for use.

Verify Classification: Ensure your device is correctly classified as Class C under the EU Medical Device Regulation (MDR) 2017/745.

Confirm Classification: Verify that your device is correctly classified as Class C according to the MDR.

Determine Device Classification: Confirm that your device is correctly classified as Class C according to the EU Medical Device Regulation (MDR) 2017/745.

Obtaining EU CE certification for Class C medical devices can be a time-consuming process. The duration typically ranges from several months to over a year, depending on various factors such as the complexity of the device, the efficiency of your preparation, and the responsiveness of the Notified Body.

Determine Classification: Confirm that your device is correctly classified as Class C based on its risk level and intended use.

Ongoing Compliance: Ensure continued compliance with MDR requirements, including any changes or updates to the regulation.

Monitoring: Continuously monitor the device's performance and safety once it is on the market.