Labeling under MDR

Accurate and compliant labeling is a fundamental requirement for placing medical devices on the European market. Under the EU MDR 2017/745, manufacturers must ensure that all information supplied with a device - including labels, Instructions for Use (IFU), the Declaration of Conformity (DoC), implant cards (where applicable) and other accompanying documentation - is complete, accurate and compliant with regulatory requirements. Proper labeling supports the safe and effective use of medical devices, enhances traceability through the Unique Device Identification (UDI) system and facilitates regulatory compliance throughout the product lifecycle.

This training is specifically designed to provide medical device professionals with a practical understanding of MDR labeling requirements and the obligations relating to information supplied by the manufacturer. Participants will learn how to develop compliant labeling and accompanying documentation, implement UDI requirements and avoid common regulatory deficiencies.

Key Topics Covered:

• Overview of labeling requirements under the EU MDR 2017/745
• Information to be supplied by the manufacturer, including labels, Instructions for Use (IFU), Declaration of Conformity (DoC), implant cards and other accompanying documentation
• UDI requirements, device identification and traceability obligations
• Language requirements and electronic Instructions for Use (eIFU) considerations
• Labeling requirements for different device classes and special device categories
• Common labeling deficiencies and regulatory findings
• Practical examples, case studies and Q&A sessions

Certificate: Participants receive a Certificate of Attendance of DQS MED GmbH

Target Audience: Regulatory Affairs Professionals, Quality Assurance and Quality Management personnel, Labeling specialists, Professionals responsible for preparing, reviewing or approving medical device labeling.

Benefits

• Gain a comprehensive understanding of MDR labeling and information supplied by the manufacturer requirements.
• Learn how to prepare compliant labels, IFUs, DoCs, implant cards and related documentation.
• Understand UDI requirements and their role in device identification and traceability.
• Identify and prevent common labeling deficiencies that may delay market access or regulatory approval.

Strengthen organizational processes for labeling compliance and regulatory documentation throughout the product lifecycle.