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.

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

Identify Applicable Directive: Determine the applicable EU Directive or Regulation that applies to your ventilator. Typically, medical devices fall under the Medical Devices Regulation (MDR) or the In Vitro Diagnostic Regulation (IVDR).

Notified Body Fees: For devices requiring Notified Body involvement (typically Class IIa, IIb, III devices and some IVDs), fees can range significantly. Notified Body fees cover the costs of conformity assessment activities, which may include document review, audits, testing, and inspections. Costs can vary from several thousand euros to tens of thousands, depending on the complexity of the device and the scope of assessment required.

Comprehensive Documentation: The technical documentation must be comprehensive and sufficiently detailed to demonstrate conformity with the applicable requirements of the MDR or IVDR.

Duration: Several weeks to months, depending on the readiness of technical documentation, quality management systems (QMS), and clinical evaluation.

Device Classification: Determine the correct classification of your medical device according to the MDR or IVDR. Device classification determines the applicable conformity assessment route and requirements.