The timeline for CE certification of ventilators in the EU can vary significantly depending on several factors, including the classification of the device, the involvement of Notified Bodies, and the readiness of documentation. Here’s a general timeline breakdown:

1. Preparation Phase

• 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).

• Technical Documentation Preparation: Compile and prepare comprehensive technical documentation, including design specifications, risk assessment, clinical evaluation, verification, validation, labeling, and instructions for use.

• Quality Management System (QMS) Implementation: Establish and implement a QMS compliant with ISO 13485:2016 or an equivalent standard.

• Clinical Evaluation: Conduct clinical evaluations or studies to demonstrate the safety and performance of the ventilator.

• Risk Management: Perform risk assessment and implement risk management processes according to ISO 14971.

2. Notified Body Involvement (if applicable)

• Notified Body Selection: Choose and engage with a Notified Body (NB) if the conformity assessment procedure requires NB involvement.

• Technical File Submission: Submit the technical documentation to the NB for review and assessment.

• Audit or Testing (if applicable): Undergo audits or testing as required by the NB to verify conformity with the MDR.

3. Certification Process

• Technical File Review: The NB reviews the technical documentation, including verification of compliance with applicable standards and regulations.

• Issue of Certificate: Upon successful completion of the assessment, the NB issues the relevant certificate (e.g., EC type-examination certificate, quality management system certificate).

4. Declaration of Conformity (DoC)

• Preparation and Signing: Prepare and sign the Declaration of Conformity (DoC) confirming that the ventilator complies with all applicable requirements of the MDR.

5. Post-Certification Activities

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

• Market Entry: Register the ventilator with national competent authorities in EU member states where it will be marketed, if required.

General Timeline Estimates

• Class I Devices (Self-Certification): Typically, the timeline ranges from 3 to 6 months, depending on the readiness of documentation and internal processes.

• Class IIa, IIb, III Devices (Involving Notified Body): The timeline can vary from 6 months to over a year. It includes the additional time needed for Notified Body assessment, which may involve audits, testing, and review of technical documentation.

• Complex Devices (Class III): Devices with higher risk classifications or novel technologies may require longer timelines, often exceeding a year due to more rigorous assessment and review processes.

Factors Affecting Timeline

• Notified Body Availability: Availability of Notified Bodies and their workload can impact the timeline for assessment and certification.

• Documentation Readiness: The time taken to compile comprehensive technical documentation, conduct clinical evaluations, and implement a QMS can affect the overall timeline.

• Regulatory Changes: Changes in regulatory requirements or updates to the MDR may necessitate additional time for compliance adjustments.

• Company Preparedness: The readiness of the manufacturer to respond to requests for additional information or to address any findings from audits or assessments can influence the certification timeline.

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