Regulatory Framework: Ensure that your device complies with the MDR, which outlines the essential requirements for medical devices in the EU.

Confirm that your device is classified as Class D under MDR, based on its intended use and risk to patients.

EU CE certification for Class D medical devices is part of the European Union's Medical Device Regulation (MDR) framework, which regulates medical devices in the EU market. Class D is the highest risk category for medical devices, generally including devices that are intended for high-risk procedures or have a significant impact on patient health.

Applying for EU CE certification for Class D medical devices involves several key steps. First, ensure your device meets the EU Medical Device Regulation (MDR) requirements.

Preparation of Documentation (2-3 months): Assembling technical documentation, clinical evaluations, risk management reports, and ensuring your Quality Management System (QMS) is in place.

Frequency: The Notified Body conducts periodic surveillance audits, often annually, to ensure ongoing compliance with the EU Medical Device Regulation (MDR) and the quality management system (QMS).

European Economic Area (EEA): CE certification is mandatory for selling medical devices in the EU and EEA countries. It grants access to a large and highly regulated market.

Preparation of Documentation (2-3 months): Gathering and preparing technical documentation, including clinical evaluations and risk management reports.