Applying for CE certification for ventilators to market them in the European Union involves a structured process, specific documentation requirements, and several key considerations. Here’s an overview:

Process for CE Certification of Ventilators:

1. Determine Applicable Regulation

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

2. Classification of the Device

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

3. Conformity Assessment Procedure

• Select the appropriate conformity assessment procedure based on the classification:
  • Class I: Self-certification based on conformity with general safety and performance requirements (Annex I).
  • Class IIa, IIb, III: Requires involvement of 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 comprehensive technical documentation demonstrating compliance with the essential requirements of the MDR. Required documents typically include:
  • Device description, specifications, and intended use
  • Design and manufacturing information
  • Risk assessment and risk management documentation (ISO 14971)
  • Clinical evaluation report demonstrating safety and performance
  • Verification and validation data
  • Labeling and instructions for use
  • Packaging information

5. Quality Management System (QMS)

• Implement a QMS compliant with ISO 13485:2016 or an equivalent standard. The QMS should cover design, manufacturing, and post-market surveillance processes.

6. Clinical Evaluation

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

7. Notified Body Involvement (if applicable)

• Engage a Notified Body for assessment if required by the chosen conformity assessment procedure. The NB reviews technical documentation, conducts audits or tests, and issues the relevant certificates.

8. Declaration of Conformity (DoC)

• Issue a Declaration of Conformity (DoC) stating that the ventilator meets the essential requirements of the MDR.

9. CE Marking

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

10. Post-Market Surveillance (PMS)

• Establish a PMS system to monitor the performance and safety of the ventilator after it is placed on the market. This includes handling complaints, incidents, and implementing corrective actions.

11. Registration with Competent Authorities

• Depending on the EU member state requirements, register the ventilator with the national competent authorities before placing it on the market.

Required Documents for CE Certification:

• Technical File: Comprehensive documentation proving compliance with MDR requirements.
• Quality Management System Documentation: Evidence of a compliant QMS.
• Clinical Evaluation Report: Demonstrates clinical data supporting the safety and performance of the ventilator.
• Declaration of Conformity: States conformity with MDR essential requirements.
• Labeling and Instructions for Use: Includes all required information for safe and effective use of the ventilator.
• Documentation of Notified Body Assessment (if applicable): Certificates and reports issued by the Notified Body.

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