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- 2024-08-19For EU CE certification of Class D medical devices, the technical documentation, also known as the Design Dossier, must be comprehensive and detailed to demonstrate compliance with the EU Medical Device Regulation (MDR) 2017/745.
- Technical Documentation and QMS: 3-6 months. This includes preparing and compiling all required documentation, implementing a Quality Management System (QMS), and conducting necessary clinical trials or testing.
- Understand MDR Requirements: Ensure you are familiar with all aspects of the MDR, which outlines the regulatory requirements for medical devices in the EU.
- Verify Classification: Confirm that your device is correctly classified as Class D under the EU Medical Device Regulation (MDR) 2017/745 based on its intended use and risk level.
- Device Description: Detailed information about the device, including its design, intended use, and operational principles.
- Classification: Confirm that your device is classified as Class D under the EU Medical Device Regulation (MDR) 2017/745.
- Find a Notified Body: Choose an accredited Notified Body designated to assess Class D medical devices. The Notified Body is responsible for reviewing your Technical Documentation and conducting necessary audits.
- 2024-08-19Application Fees: Varies based on the Notified Body and complexity of the device. Fees can range from €10,000 to €50,000 or more.
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