MDSS News & Views

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:

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  Clarifies some of the existing definitions.
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  Introduces a new Manufacturer’s Incident Report and the new template for Field Safety Notice.
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  Introduces device specific vigilance guidance.
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  Provides further detail in relation to the area of the coordination of vigilance issues amongst Competent Authorities.
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  Clarifies the differences between the EU NCAR exchange and the IMDRF NCAR exchange.