Applying for EU CE certification for medical devices involves several key steps to ensure compliance with the Medical Devices Regulation (MDR) or the In Vitro Diagnostic Medical Devices Regulation (IVDR). Here’s a general outline of the process:

1. Classification: Determine the correct classification of your medical device according to Annex VIII of the MDR or IVDR. Classification depends on the intended use, potential risks, and duration of contact with the body.

2. Conformity Assessment Procedure: Select the appropriate conformity assessment procedure based on your device's classification. This could involve self-certification (for low-risk devices), involving a notified body (for higher-risk devices), or full quality assurance.

3. Technical Documentation: Prepare comprehensive technical documentation that includes details such as device description, design specifications, risk assessment, clinical evaluation (if required), labeling, and instructions for use.

4. Quality Management System: Ensure that your manufacturing process meets the requirements of the MDR/IVDR. For some devices, certification to ISO 13485:2016 is mandatory.

5. Notified Body Involvement: If your device requires the involvement of a notified body (e.g., Class IIa, IIb, III medical devices under MDR), choose and engage with a notified body early in the process. They will assess your technical documentation and conduct audits if necessary.

6. Clinical Evaluation: Conduct a clinical evaluation for devices where required by the regulations. This involves assessing clinical data to demonstrate the device's safety and performance.

7. CE Marking: Once all requirements are fulfilled, affix the CE mark to your device. The CE mark indicates compliance with EU regulations and allows market access within the European Economic Area (EEA).

8. Post-Market Surveillance: Implement a post-market surveillance system to monitor the performance and safety of your device after it enters the market.

9. Registration: For some devices and under certain circumstances, register your device and economic operator information in the EUDAMED database.

10. Periodic Updates: Keep abreast of regulatory changes and update your documentation and processes accordingly.

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