Prepare Documentation: Gather all required documents including technical specifications, quality management system documentation, and proof of compliance with safety standards.

Technical Documentation: Preparing the Design Dossier, clinical evaluations, risk management documentation, and performance testing. This phase also includes setting up or updating your Quality Management System (QMS) to comply with ISO 13485.

Notified Body Audits: The Notified Body will conduct periodic surveillance audits, typically on an annual basis, to ensure that the manufacturer continues to comply with the EU Medical Device Regulation (MDR) 2017/745 and ISO 13485:2016. These audits assess the effectiveness of the Quality Management System (QMS) and check for any non-conformities.

EU Market: Certification allows your device to be marketed and sold within the European Economic Area (EEA), which includes all EU member states as well as Iceland, Liechtenstein, and Norway.

Technical Documentation: Preparing the comprehensive technical documentation, including the Design Dossier, clinical evaluations, and risk management documentation.

Regulatory Approval: The device complies with the safety, performance, and quality standards defined by the MDR.

Review MDR: Study the EU Medical Device Regulation (MDR) 2017/745 to understand the specific requirements for Class D devices.

Understand MDR Requirements: Familiarize yourself with the MDR 2017/745, particularly the sections applicable to Class D devices (high-risk devices).