[TECH LETTER] Sufficient financial coverage

The MDR and IVDR introduce the requirement for medical device manufacturers to provide “sufficient financial coverage” to provide compensation for damage caused by a defective device.
 
The MDR/IVDR however do not specify what may be considered “sufficient”, which can make it difficult for manufacturers to determine the level of coverage that is required to satisfy this requirement.
 
This Downloadable Tech’letter aims at clarifying the factors that should be considered when evaluating whether a financial coverage is “sufficient”.
 

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