To apply for CE certification of ventilators in the European Union, several conditions must be met to ensure compliance with the Medical Devices Regulation (MDR). Here are the key conditions:

1. Classification of the Ventilator

• 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.

2. Conformity Assessment

• Selection of Conformity Assessment Procedure: Choose the appropriate conformity assessment procedure based on the device's classification:
  • Class I: Self-certification based on conformity with general safety and performance requirements (Annex I).
  • Class IIa, IIb, III: Involvement of a Notified Body (NB) is required. Procedures include Annex II (full quality assurance), Annex III (EC type examination), Annex IV (production quality assurance), or Annex V (product quality assurance).

3. Technical Documentation

• Comprehensive Technical File: Prepare a technical file (technical documentation) that demonstrates conformity with the essential requirements of the MDR. This includes detailed information on design, manufacturing, risk assessment, clinical evaluation, verification, validation, labeling, and instructions for use.

4. Quality Management System (QMS)

• ISO 13485 Compliance: Implement and maintain a quality management system (QMS) that complies with ISO 13485:2016 or an equivalent standard. The QMS should cover design, development, production, and post-market surveillance processes.

5. Clinical Evaluation

• Clinical Data: Conduct a clinical evaluation to demonstrate the safety and performance of the ventilator. This involves reviewing relevant scientific literature and, if necessary, performing clinical investigations.

6. Risk Management

• ISO 14971 Compliance: Perform a risk assessment and implement a risk management process according to ISO 14971. Identify hazards associated with the ventilator, assess risks, and implement measures to mitigate those risks.

7. Post-Market Surveillance (PMS)

• PMS System: Establish a post-market surveillance system to monitor the performance and safety of the ventilator after it is placed on the market. This includes collecting and evaluating data on the device's performance, handling complaints, incidents, and implementing corrective actions as necessary.

8. Labeling and Instructions for Use

• Comprehensive Labeling: Ensure that the ventilator is properly labeled with the CE mark and includes all required information, such as device identification, manufacturer details, intended use, warnings, and instructions for use.

9. Declaration of Conformity (DoC)

• Issuance of DoC: Prepare and issue a Declaration of Conformity (DoC) stating that the ventilator meets all applicable requirements of the MDR. The DoC must be signed by a person authorized to legally bind the manufacturer.

10. Compliance with General Safety and Performance Requirements (GSPR)

• GSPR Compliance: Ensure that the ventilator complies with the general safety and performance requirements laid out in Annex I of the MDR. These requirements cover aspects such as design, manufacture, usability, and performance to ensure the device's safety and efficacy.

11. Authorized Representative (if applicable)

• EU Authorized Representative: If the manufacturer is based outside the EU, appoint an authorized representative within the EU responsible for liaising with competent authorities.

12. Market Strategy

• Market Entry Plan: Develop a strategy for market entry, including translation of documentation into relevant languages and registration with national competent authorities in EU member states where the ventilator will be marketed.

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