Product Information: Detailed description of the device, including its intended use, function, and operation.

Technical Documentation and QMS Setup: Preparing the required documentation and implementing a Quality Management System (QMS) can take several months. This phase includes gathering device specifications, risk assessments, clinical evaluations, and establishing QMS procedures.

Regulation: Ensure compliance with the EU Medical Device Regulation (2017/745). This includes adhering to the general safety and performance requirements outlined in the regulation.

Technical File: Include device description, design and manufacturing information, risk assessment, clinical evaluation, labeling, and user manuals.

Device Description: Detailed information about the device, its intended use, and how it works.

Determine Classification: Confirm that your device is classified as Class B under the EU Medical Device Regulation (MDR) 2017/745.

Select a Notified Body: Choose an accredited Notified Body that is authorized to assess your type of device. You can find a list of Notified Bodies on the European Commission’s NANDO (New Approach Notified and Designated Organisations) database.

Notified Body Fees: The cost for Notified Body services can range from €5,000 to €15,000 or more. This includes the review of technical documentation and QMS, as well as audit fees.