Device Description: Detailed information about the device, including its intended use and mode of action.

Determine Classification: Confirm that your device falls under Class B based on its intended use and risk level.

Prepare Technical Documentation: This includes detailed product specifications, risk analysis, and clinical evaluations.

For EU CE certification of Class I medical devices, the technical documentation must be comprehensive and align with the requirements set forth by the EU Medical Device Regulation (MDR) 2017/745 or the In Vitro Diagnostic Device Regulation (IVDR) 2017/746.

Compile Documentation: Ensure you have all necessary technical documentation, including device description, design and manufacturing details, risk management, clinical evaluation (if required), instructions for use, and quality management system documentation.

Device Description: Detailed information about the device, including its intended purpose, design, and how it operates.

Verify Classification: Confirm that your device is indeed classified as Class I according to the EU Medical Device Regulation (MDR) 2017/745 or the In Vitro Diagnostic Device Regulation (IVDR) 2017/746.

Technical Documentation Preparation: Costs for developing technical documentation, risk assessments, clinical evaluations, and labeling can vary widely. This may involve consulting fees, internal resources, and document preparation costs. Typically, this can range from a few thousand to several tens of thousands of euros, depending on the complexity of the device.