The timeline for processing EU CE certification of medical devices can vary significantly based on several factors, including the device classification, involvement of Notified Bodies, completeness of documentation, and regulatory updates. Here's a general outline of the typical timeline:

1. Preparation Phase:

   • Duration: Several weeks to months, depending on the readiness of technical documentation, quality management systems (QMS), and clinical evaluation.
   • Activities: Prepare comprehensive technical documentation, establish or update QMS to comply with ISO 13485:2016 or equivalent, conduct clinical evaluations, and compile necessary documentation for submission.

2. Submission to Notified Body (if applicable):

   • Duration: Varies based on Notified Body availability and submission requirements.
   • Activities: Submit the Technical File and application for conformity assessment to the selected Notified Body. This step initiates the formal review process.

3. Conformity Assessment by Notified Body:

   • Duration: Typically several months.
   • Activities: Notified Body reviews the technical documentation, conducts audits (if required), and may perform testing or inspections to verify compliance with EU regulations and standards.

4. Decision and Issuance of Certificate:

   • Duration: After completion of conformity assessment.
   • Activities: Notified Body issues a certificate of conformity if all requirements are met, confirming compliance with EU regulations and allowing the affixing of the CE marking.

5. CE Marking and Market Access:

   • Duration: Upon receipt of the certificate.
   • Activities: Affix the CE marking to the device to indicate compliance with EU requirements. The device can then be legally marketed within the EU and EEA.

Considerations:

• Device Classification: Higher-risk devices (e.g., Class IIb, III) generally require more extensive assessment and may have longer processing times.

• Notified Body Availability: The timeline can be influenced by the Notified Body's workload and availability for assessments.

• Documentation Completeness: Ensuring all required documentation is complete and accurate at the time of submission can expedite the process.

• Regulatory Updates: Changes in regulations or standards may impact timelines, so staying informed is crucial.

• Post-Market Surveillance: Implementing a system for post-market surveillance and reporting is required after obtaining CE certification.

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