Obtaining CE certification for ventilators involves several key processes and steps, outlined below:

1. Determine Applicable Regulation

• 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.

2. Classification of the Device

• Classify the Device: Classify your ventilator according to the MDR's classification rules (Class I, IIa, IIb, or III). Classification depends on factors such as intended use, duration of use, and invasive nature.

3. Conformity Assessment Procedure

• Select Conformity Assessment Procedure: Choose the appropriate conformity assessment procedure based on the classification:
  • Class I: Self-assessment based on general safety and performance requirements.
  • Class IIa, IIb, III: Involves assessment by a Notified Body (NB). Procedures include Annex II (full quality assurance), Annex III (EC type examination), Annex IV (production quality assurance), or Annex V (product quality assurance).

4. Technical Documentation

• Prepare Technical Documentation: Compile technical documentation demonstrating conformity with the essential requirements of the MDR. Documentation typically includes:
  • Device description, specifications, and intended use
  • Risk management documentation (ISO 14971)
  • Clinical evaluation report
  • Labeling and instructions for use
  • Verification and validation data

5. Quality Management System

• Establish Quality Management System: Implement a quality management system (QMS) compliant with ISO 13485:2016 or equivalent. The QMS should cover design, production, and post-market surveillance processes.

6. Clinical Evaluation

• Perform Clinical Evaluation: Conduct a clinical evaluation to demonstrate the safety and performance of the ventilator. This involves reviewing relevant scientific literature and, if necessary, conducting clinical studies.

7. Notified Body Involvement (if applicable)

• Involve Notified Body: If required by the conformity assessment procedure, involve a Notified Body for assessment. The NB reviews technical documentation, quality system, and may perform audits or tests.

8. Declaration of Conformity (DoC)

• Issue Declaration of Conformity: Once conformity is verified, issue a Declaration of Conformity stating that the ventilator complies with the MDR requirements.

9. CE Marking

• Affix CE Mark: Affix the CE mark to the ventilator and prepare the required labeling according to MDR requirements.

10. Post-Market Surveillance

• Implement Post-Market Surveillance: Establish a post-market surveillance system to monitor the performance and safety of the ventilator after it is placed on the market.

11. Registration with Competent Authorities

• Register with Competent Authorities: In some EU member states, register the ventilator with the national competent authority before placing it on the market.

12. Keep Documentation Updated

• Maintain Updated Documentation: Ensure that technical documentation remains updated to reflect any changes in regulations or standards.

Additional Considerations

• Authorized Representative: If your company is located outside the EU, appoint an authorized representative within the EU.

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