CE Marking Approval Process

CE Marking approval assures the public that your device conforms with applicable EU legislation and allows your product to be sold in all EU member countries legally. The majority of medical device manufacturers are eager to launch their products because they want to start achieving their financial objectives and want their innovation to start assisting patients.

It is essential and mandated by law that you make sure you are abiding by the stringent rules of the medical devices regulations (law of the land) where you intend to sell your device before sales can happen. Failure to do so could create legal hurdles and, more significantly, your end consumers.

If you’re not familiar with the MDR Class IIa/IIb/III or IVDR Class A/B/C/D CE Marking approval process, the following information on this page will educate you on all the steps involved in the process. I3CGLOBAL Consultants play a major role in guiding manufacturers through the approval process as per MDR and IVDR by:

• Taking the most efficient pathway for obtaining CE Marking, considering the device classification and intended use
• Prepare technical documentation, covering risk management, manufacturing data, and performance data
• Preparation of a CER that demonstrates the clinical safety and performance of the device based on clinical data
• Preparation of a PER that demonstrates the performance of the device based on analytical data
• Help manufacturers choose an appropriate Notified Body for their device’s conformity assessment
• Submit technical documentation to the Notified Body and manage ongoing communications and responses to review comments
• Ensure that device labelling meets EU requirements, including language and content specifications
• Provide European Authorized Representative service for Foreign manufactures

The MDR CE marking approval criteria for medical devices are governed by the European Union’s Medical Device Regulation depending on the type and risk class of medical device. Here are some key aspects of the approval criteria:

• Conformity Assessment Procedure and route of CE marking
• Technical Documentation
• Level of medical device Quality Management System implemented
• Clinical Evaluation
• Labelling and Instructions for Use
• Post-Market Surveillance
• Post-Market Clinical Follow-Up
• Risk Management
• Unique Device Identification (UDI)
• GAP assessment of MDQMS
• EU Representative

These criteria aim to ensure that medical devices placed on the European market meet high standards of safety, performance, and quality, ultimately safeguarding the health and well-being of patients and users.