MDR Liability Insurance

Ed Panek

QA RA Small Med Dev Company
Staff member
Super Moderator
#1
"16. Natural or legal persons may claim compensation for damage caused by a defective device in accordance with applicable Union and national law. Manufacturers shall, in a manner that is proportionate to the risk class, type of device and the size of the enterprise, have measures in place to provide sufficient financial coverage in respect of their potential liability under Directive 85/374/EEC, without prejudice to more protective measures under national law. "

We currently have liability insurance for our EU products, is it acceptable to continue our same policy limits from MDD-->MDR?
 
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Billy Milly

Starting to get Involved
#2
Our situation is very similar and we do not intend to change it for now. From the aspect of regulations, limits are not defined - you have to identify "sufficient coverage" yourself (systematic risk analysis?).
You could also consider recall insurance (although not a requirement, it can be beneficial for the company).
 
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