To apply for Class B medical device CE certification in the EU, follow these steps:

Steps to Apply:

1. Prepare Documentation:

   • Technical File: Include device description, design and manufacturing information, risk assessment, clinical evaluation, labeling, and user manuals.
   • Quality Management System (QMS): Implement and document a QMS compliant with ISO 13485.

2. Select a Notified Body:

   • Find a Notified Body: Choose an accredited Notified Body from the European Commission’s NANDO (New Approach Notified and Designated Organisations) database. Ensure the Notified Body is designated for Class B medical devices.
   • Contact the Notified Body: Reach out to them for specific application procedures and requirements.

3. Submit Application:

   • Application Forms: Complete and submit any forms required by the Notified Body.
   • Technical Documentation: Provide the technical file and QMS documentation to the Notified Body for review.

4. Assessment by Notified Body:

   • Review: The Notified Body will review your documentation and may conduct an audit of your manufacturing facilities and QMS.
   • Additional Information: Be prepared to provide additional information or make corrections if requested by the Notified Body.

5. Certification:

   • Receive CE Certificate: If your device meets all requirements, the Notified Body will issue a CE certificate, allowing you to market your device in the EU.

6. Post-Market Surveillance:

   • Monitor Device Performance: Implement a post-market surveillance system to track the device's performance and report any issues as required.

Where to Handle It:

1. Notified Body:

   • Role: The Notified Body is responsible for reviewing your technical documentation, assessing your QMS, and issuing the CE certificate.
   • Contact Information: Obtain contact details from the NANDO database.

2. European Commission:

   • Database: Use the NANDO database to find a list of accredited Notified Bodies and their contact details.

3. Local Regulatory Authority:

   • Optional: In some cases, local regulatory authorities may provide guidance or additional requirements, but the main certification process is handled by the Notified Body.