EU MDR - Liability Clause per article 31

[sriramsl]

Dear Experts - Ronen, Marcelo et al

In the EU MDR there is a liability clause as per article 31 :

"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/EEC ). Such measures should be proportionate to the risk class, type of device and the size of the enterprise. In this context, it is also appropriate to lay down rules concerning the facilitation, by a competent authority, of the provision of information to persons who may have been injured by a defective device "

Does this mean that the manufacturers have to take an Product Liability Insurance? and will this be insisted by the Competent Authority before approval of the product?

 

[mikinnear]

Hi, can you link a source to this paragraph, and page number if applicable please.

Thanks,
Mike.

 

[Marcelo]

The text from the OP is from the preamble ("Whereas"...")

The formal requirement is in Article 10 - General obligations of manufacturers

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.

Right now, it's really not clear what to expect from this requirement. In on hand, it does seem to require that the manufacturer complies with Directive 85/374/EEC (which they should already be doing). On the other hand, "measures in place to provide sufficient financial coverage" does seem to imply that insurance may be required.

I expect that we will have a guidance on this in the future.

 

[yodon]

Here's a link to the MDR online: https://eur-lex.europa.eu/legal-content/ENG/TXT/PDF/?uri=CELEX:32017R0745&from=EN

There are actually a couple of places where this is mentioned. Item 31 in the main body (?) is on p. 15:

"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. Such measures should be proportionate to the risk class, type of device and the size of the enterprise. In this context, it is also appropriate to lay down rules concerning the facilitation, by a competent authority, of the provision of information to persons who may have been injured by a defective device."

And then again in article 10, item 16, p. 84:

"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."

 

[mikinnear]

Ah yes,

Sorry with the mention of article 31 in the original post, that is exactly where I jumped to, on a further search I do see this text on page 15.

Kind regards,
Mike.

 

[isolytical]

Although not stated, it is clear that the word 'commensurate' strongly implies that one mitigation does not apply to all products. This is supported by the wording seen in the Directive(s). Thus to assume the PLI is required in absence of more complete product related information is erroneous.

 

[sriramsl]

Thank you Marcelo for your reply

As you said, hope we will get clarification on this from Regulatory Authority.
Regards
Sriram

 

[RobertvanBoxtel]

The requirement to have product liability Insurance is not new, also not for the medical devices in the EU.
The reference product liability Directive is applicable in these cases. And there might be more local member state requirements.

Also, look into Article 10.14 regarding information you will have to disclose to member states that can even end up at patients or Insurance companies.
The big unknown is what is sufficient coverage as there are no specifics on that, just depending on risk etc.

 

[MiamiDM]

Picking up on the requirement for liability insurance, an 'external consultant', not a NB, has recommended a review of liability insurance is covered in the Quality Manual or as part of Management Review.

Although representing 'best practice', I don't think reference to liability insurance in a QMS procedure is an expectation/requirement of the MDR.

Is my response reasonable?

Thoughts appreciated, thank you.

 

[John Broomfield]

Liability Insurance is an essential part of risk management for MD companies. So I’d expect companies to have a process in place for keeping this documented information up to date. If the auditee could not show me then I’d take this concern up with top management.