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- Core Regulation: Governs the overall requirements for medical devices in the EU, including classification, safety, performance, and documentation.
- Familiarize Yourself with the EU MDR: Review the EU Medical Device Regulation (MDR) 2017/745 to understand the specific requirements for Class C devices.
- Monitoring: Continuously monitor the device's performance and safety in the market.
- 2024-08-16General Description: Detailed information about the device, including its intended purpose, functionality, and how it works.
- Technical Documentation: Preparing the necessary documentation, including the technical file, clinical evaluation, and risk management, can take several months to a year depending on the complexity of the device and the completeness of the data.
- Ensure that your device complies with the Medical Device Regulation (MDR) 2017/745, which outlines the regulatory requirements for medical devices in the EU.
- 2024-08-16For EU CE certification of Class C medical devices, the technical documentation must be comprehensive and adhere to the requirements set out by the EU MDR 2017/745.
- Confirm that your device is correctly classified as Class C according to the EU MDR 2017/745.
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