Confirm Classification: Ensure that the device is correctly classified as Class I under the MDR or IVDR. Class I devices are generally low-risk and include products like bandages or simple surgical instruments.

Verify Classification: Confirm that your device is indeed classified as Class I under the EU Medical Device Regulation (MDR) 2017/745 or In Vitro Diagnostic Device Regulation (IVDR) 2017/746. Class I devices are typically low-risk and may include items like bandages, simple surgical instruments, or certain diagnostic tools.

Definition: CE certification indicates that a Class I medical device conforms to the relevant EU directives and regulations, ensuring that it is safe and effective for its intended use.

Confirm that your device is classified as Class I according to the EU MDR (Medical Device Regulation) 2017/745 or the EU IVDR (In Vitro Diagnostic Device Regulation) 2017/746 if it’s an IVD.

Class I Devices: These are typically lower-risk devices and may undergo self-certification. The certification process can range from a few months to six months, depending on documentation preparation and regulatory requirements.

Purpose: The annual review is conducted to assess whether the medical device continues to meet the essential requirements set out in the Medical Devices Directive (MDD) or the Medical Devices Regulation (MDR). It ensures ongoing compliance with regulatory requirements.

Market Access in Europe: The CE mark allows medical devices to be marketed and sold within the European Economic Area (EEA) without additional technical barriers related to safety and performance.

Device Classification: Lower-risk devices (such as Class I) that do not require the involvement of a Notified Body may have a faster certification process compared to higher-risk devices (Class IIa, IIb, III) that require Notified Body involvement.