Obtaining EU CE certification for medical devices involves a structured process, specific required documents, and important considerations. Here’s a detailed overview:

Process for EU CE Certification:

1. Device Classification:

   • Determine the correct classification of your medical device according to the Medical Device Regulation (MDR) or In Vitro Diagnostic Regulation (IVDR). This determines the conformity assessment route.

2. Select Conformity Assessment Route:

   • Class I Devices: Self-certification based on the manufacturer's Declaration of Conformity.
   • Class IIa, IIb, III Devices: Involvement of a Notified Body for conformity assessment, which may include audits, technical documentation review, and testing.
   • In Vitro Diagnostic Devices: Generally require Notified Body involvement for conformity assessment, including performance evaluation and verification.

3. Prepare Technical Documentation:

   • Device Description: Detailed specifications and intended use.
   • Design and Manufacturing Information: Technical drawings, manufacturing processes, etc.
   • Risk Management Documentation: Risk analysis and mitigation strategies.
   • Clinical Evaluation Report: For medical devices, based on clinical data and literature review.
   • Labeling and Instructions for Use: Ensure compliance with labeling requirements.
   • Post-Market Surveillance Plan: Outline how you will monitor device performance post-market.

4. Implement Quality Management System (QMS):

   • Establish a QMS compliant with ISO 13485:2016 or equivalent standards.
   • QMS should cover design controls, production processes, risk management, and post-market surveillance.

5. Clinical Evaluation (for medical devices):

   • Conduct a clinical evaluation to demonstrate safety and performance based on clinical data and scientific literature.

6. Compile Technical File:

   • Gather all technical documentation into a Technical File that demonstrates conformity with relevant regulations and standards.

7. Declaration of Conformity:

   • Prepare and sign the Declaration of Conformity, affirming that your device meets all applicable requirements of the MDR or IVDR.

8. Submit to Notified Body (if applicable):

   • If your device requires Notified Body involvement, submit the Technical File and application for conformity assessment.

9. Conformity Assessment by Notified Body:

   • Notified Body reviews technical documentation, may conduct audits, tests, or inspections as necessary.

10. CE Marking:

    • Affix the CE marking to your device once conformity is verified. CE marking indicates compliance with EU regulations and allows market access.

11. Post-Market Surveillance:

    • Implement a system to monitor device performance and report adverse events post-market.

Required Documents:

• Technical File: Includes all technical documentation demonstrating conformity with Essential Requirements (MDR) or General Safety and Performance Requirements (IVDR).
• Clinical Evaluation Report: Required for medical devices, based on clinical data and literature review.
• Quality Management System Documentation: Evidence of compliance with ISO 13485 or equivalent.
• Declaration of Conformity: Signed document affirming compliance.
• Labeling and Instructions for Use: Ensure compliance with EU labeling requirements.

Considerations:

• Regulatory Updates: Stay informed of changes to EU regulations and standards that may impact certification requirements.
• Notified Body Selection: Choose a Notified Body with expertise relevant to your device type and ensure they are designated for the appropriate conformity assessment procedures.
• Timeline and Costs: Plan for adequate time and budget for preparation, Notified Body involvement (if applicable), and ongoing compliance activities.
• Authorized Representative: If your company is based outside the EU, appoint an Authorized Representative within the EU.
• Language Requirements: Ensure all documentation is in the official language of the country where your Notified Body is located or in a language accepted by them.

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