A large release of the Medical Device Coordination Group (MDCG) Guidance on Vigilance has been published to the European Commission website: MDCG 2024-1, MDCG 2024-1-1, MDCG 2024-1-2, MDCG 2024-1-3, and MDCG 2024-1-4. Each guidance falls into the “Device Specific Vigilance” category, and the goal of these updates is to harmonize vigilance reporting, whilst also providing guidance for manufacturers of specific devices.
What does this report assist manufacturers on?
- What to report to ensure compliance with statutory reporting requirements within the MDR
- Examples of what is reportable as device-related problems that caused or contributed to incidents or serious incidents
- Clinical references and guidelines that can be used by manufacturers to identify incident examples and complications
If you have any inquiries or need additional clarification regarding The European Commision’s updates on the MDCG Device Specific Vigilance Guidelines, feel free to reach out to us.
Learn how MedEnvoy can assist you:
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