Drugdu.com expert's response:

When applying for the CE certification for IVD self-test products in the EU, attention should be paid to the following aspects:

Ⅰ. Understanding the IVDR Regulatory Requirements

Regulatory Content: IVD self-test products need to comply with the regulations of the In Vitro Diagnostic Medical Devices Regulation (IVDR, Regulation (EU) 2017/746).

Product Classification: According to the IVDR, IVD products are classified into four risk categories: A, B, C, and D. Self-test products, which typically involve patients performing their own tests, may fall into higher risk categories, requiring special attention to relevant audit requirements.

Ⅱ. Preparing Technical Documentation

Completeness: Technical documentation should include product instructions, technical specifications, validation reports, quality control manuals, etc., and should be organized and numbered according to the order specified in Appendix II of the IVDR.

Accuracy: The content of the documentation should be accurate and reflect the true performance and safety of the product.

Language Requirements: Communicate with the Notified Body in advance to determine the language requirements for technical documentation, as some Notified Bodies may require quality manuals in English.

Ⅲ. Choosing a Notified Body

Qualification Requirements: The Notified Body must be recognized by the European Commission and possess the necessary practicing qualifications.

Professional Competence: Choose a Notified Body with extensive experience in certifying IVD products to ensure a smooth certification process.

Ⅳ. Application Process

Submission of Application: Submit the certification application, including technical documentation and application forms, to the selected Notified Body.

Audit and Evaluation: The Notified Body will review the submitted technical documentation and assess key aspects such as production equipment, production processes, and quality systems.

Rectification and Response: Address any issues raised during the audit and provide timely responses to the Notified Body.

Certificate Issuance: If the product meets the CE certification requirements, the Notified Body will issue a CE certification certificate.

Ⅴ. Continuous Monitoring and Updates

Quality Control: After obtaining CE certification, ensure that every manufacturing step undergoes quality monitoring and regularly conduct inspections and tests of production equipment and processes.

Documentation Updates: According to CE certification and European Authorized Representative registration requirements, update product technical documentation and application materials promptly and provide them to the certification body as needed.

Notification and Handling: Inform the authorized representative of any production changes and product defects and take appropriate measures to address them. At the same time, comply with relevant regulations and requirements, such as emergency notifications for suspected adverse reactions, withdrawal and disposal of expired products, etc.

Ⅵ. Other Considerations

Time Planning: The entire certification process can be time-consuming, so manufacturers are advised to plan ahead to ensure that products can obtain CE certification and be launched on the market in a timely manner.

Cost Budgeting: Applying for CE certification involves certain fees, including application fees, audit fees, and testing fees. Manufacturers should prepare a cost budget in advance.

In summary, applying for CE certification for IVD self-test products in the EU requires attention to multiple aspects, including understanding regulatory requirements, preparing technical documentation, choosing a Notified Body, following the application process, continuous monitoring and updates, and other considerations. Only by fully preparing and carefully executing these steps can manufacturers ensure that their products successfully obtain CE certification and are legally launched on the market.