Liability Insurance Requirements under the MDR - p. 15 (item 31)

yodon

Staff member
Super Moderator
#1
Poked around but couldn't find anything.

Started slogging through the MDR and hit a bump on p. 15 (item 31). The text is:

In view of the fact that natural or legal persons can claim compensation for damage caused by a defective device in accordance with applicable Union and national law, it is appropriate to require manufacturers to have measures in place to provide sufficient financial coverage in respect of their potential liability under Council Directive 85/374/EEC1.

I'm curious what folks plan on doing about this. Might this be something that is in effect immediately; i.e., no transition period for devices already on the market?
 
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Ronen E

Problem Solver
Staff member
Moderator
#2
Poked around but couldn't find anything.

Started slogging through the MDR and hit a bump on p. 15 (item 31). The text is:

In view of the fact that natural or legal persons can claim compensation for damage caused by a defective device in accordance with applicable Union and national law, it is appropriate to require manufacturers to have measures in place to provide sufficient financial coverage in respect of their potential liability under Council Directive 85/374/EEC1.

I'm curious what folks plan on doing about this. Might this be something that is in effect immediately; i.e., no transition period for devices already on the market?
Hi,

Please note that that item is part of the preamble; I don't think it is legally binding in itself.

Article 10 s. 16 (which is binding) reads:

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.
That seems to be the only normative (binding) reference to manufacturers' product liability in the MDR.

I think that in that context there's nothing new here because the practice is already dictated by Directive 85/374/EEC (apparently amended last in 1999). The MDR only makes it explicit that medical devices manufacturers must comply with that directive, and also highlights that the compliance should be "proportionate to the risk class, type of device and the size of the enterprise". Perhaps (hopefully) future guidance will make that phrase more explicit.
 
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