Class I Devices: Typically, Class I devices that do not require the involvement of a Notified Body (self-certification) may have lower certification costs compared to higher-risk classes.

Complete and Clear Documentation: Technical documentation must be complete, accurate, and clear, providing all necessary information for assessment and approval.

Classification and Conformity Assessment Decision: Determine the correct classification of the ventilator and select the appropriate conformity assessment procedure (self-certification or involving a Notified Body).

Correct Classification: Determine the correct classification of the ventilator according to the rules set out in Annex VIII of the MDR. The classification depends on factors such as intended use, duration of use, and invasive nature of the device.

Device Description: Detailed description of the ventilator, including its intended use, specifications, and features.

Identify whether your ventilator falls under the Medical Devices Regulation (MDR) or In Vitro Diagnostic Regulation (IVDR). Ventilators typically fall under the MDR.

Notified Body Fees: If your ventilator falls under Class IIa, IIb, or III, you will likely need involvement from a Notified Body (NB). Fees for NB assessment can vary significantly depending on the complexity of the device and the chosen conformity assessment route. Fees typically range from several thousand to tens of thousands of euros.

Classification: Determine the correct classification of your ventilator (Class I, IIa, IIb, or III) based on its intended use, duration of use, and invasive nature. This classification determines the level of scrutiny required for conformity assessment.