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  • MDSS News & Events

    MDSS News & Views

Revised list of IMDRF codes also includes Annex G (component codes)

The International Medical Device Regulatory Forum (IMDRF) published the last piece of a code system which may be used worldwide for various applications. In Europe the code system is needed for notifying incidents with the Competent Authorities. The manufacturer Incident Report (MIR) is the tool for that and requires these codes in various section of this form.

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Categories: News

EC Issues Additional Guidance on Device Vigilance System

Someone may say it comes late in the game since MDR should NOW be in implemented but it is helpful for the new MIR form and for a better understanding of the collaboration among authorities.

Additional Guidance Regarding the Vigilance System as outlined in MEDDEV 2.12-1 rev. 8

The document:


  • Clarifies some of the existing definitions.

  • Introduces a new Manufacturer’s Incident Report and the new template for Field Safety Notice.

  • Introduces device specific vigilance guidance.

  • Provides further detail in relation to the area of the coordination of vigilance issues amongst Competent Authorities.

  • Clarifies the differences between the EU NCAR exchange and the IMDRF NCAR exchange.


Categories: News
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