EU MDR - Liability Clause per article 31

isolytical

Involved In Discussions
#11
While the info about the MedDev class is not given, recall that not every type of device can injure the Pt, and the measures are variable depending on how and if a device could cause injury. Also NB that the regs only refer to the device causing injury. Also recall that this is within the device 'intended use' and 'reasonable, foreseeable mis-use'. Now it is realized that a Pt can still complain/file suit, but one should not panic that it will move forward without just cause.
Agree that some external review is needed, perhaps legal a/o financial, etc., but insurance is not the only mitigation. For example, some companies are self-insured, or even have a bond reserved for such cases. It depends on several factors. Hope this helps.
 
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MiamiDM

Starting to get Involved
#12
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.
Thanks for your comments John. Understand and acknowledged. With respect, although 'expected', is the MDR or 13485:2016 requiring liability insurance to be covered in a documented procedure?
 

John Broomfield

Staff member
Super Moderator
#13
No, this expectation is a logical extension of risk management. Some companies are big enough to self-insure but I’d want to see the evidence that risks are managed.
 

Ronen E

Problem Solver
Staff member
Moderator
#14
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.
I tend to disagree.

In the medical devices industry context, "risk management" mostly relates to risk of harm to patients or users, or, at most, to risk of QMS processes not achieving their goals. The risk being discussed here is a business (financial) risk to the company (the manufacturer), so while it's very important and worth top management's attention, it's outside the "normal" medical devices QMS scope. You could argue, though, that an ISO 13485 QMS needs to address applicable regulatory compliance so in a way any MDR requirement could come under such a QMS; but I think that due to the indirect nature of such applicability, failing to be explicit about product liability in the QMS should not be a basis for issuing a NC. IMO a requirement to comply with all applicable MDR requirements should suffice.

So, I think there's some leeway here.
 

John Broomfield

Staff member
Super Moderator
#15
Yes, ISO 14971 and the regulator tend to focus our attention on the device itself.

Every designer and manufacturer of medical devices also provides a service to its customers and we should not be ignoring service quality.

Making sure customers would be adequately compensated in the event of injury is important too. It’s part of the company’s service to its customers.
 

Ronen E

Problem Solver
Staff member
Moderator
#16
Now I'm getting confused.

Every designer and manufacturer of medical devices also provides a service to its customers
What do you mean by that? What service?

Making sure customers would be adequately compensated in the event of injury is important too. It’s part of the company’s service to its customers.
In moral terms I agree it's important, but in legal / regulatory terms it's not necessarily the manufacturer's onus (injuries can have many different causes). It's only part of the company's service if the company says so, or the law makes it mandatory.
 

John Broomfield

Staff member
Super Moderator
#17
The company's design services and manufacturing services are inherent. As is the expectation they be planned, resourced and delivered sufficient to fulfill its duty of care.

Through our tort laws this fact remains even if not mentioned in the stated scope of the management system or specified in the contract or specifically required by a regulation.

As an auditor I would make sure the record, in this instance, showed that I had advised the audit client to include the auditee's services sufficient to fulflll the audit objective.

But I am not a lawyer so please do not take this as legal advice.
 

Ronen E

Problem Solver
Staff member
Moderator
#18
The company's design services and manufacturing services are inherent. As is the expectation they be planned, resourced and delivered sufficient to fulfill its duty of care.

Through our tort laws this fact remains even if not mentioned in the stated scope of the management system or specified in the contract or specifically required by a regulation.

As an auditor I would make sure the record, in this instance, showed that I had advised the audit client to include the auditee's services sufficient to fulflll the audit objective.

But I am not a lawyer so please do not take this as legal advice.
Sorry, I think I lost you.
Anyway -
If you were my auditor and I was your auditee, I'd ask you to "show me the requirement" for every NC you'd note. If you could point to an applicable clause in an act or a regulation, I'd likely start looking into it without delay. "Applicable" doesn't necessarily mean "directly"; if you could show indirect applicability that'd be reasonable to me. But if only an expert lawyer could build and present a valid applicability case, I'd probably object until such time that such an expert actually built and presented such a case (I would probably forward it to my legal advisor for review, haha).
If you, as my auditor, gave me some advice and insisted that it was included in the record as such, I wouldn't mind. Why should I?
 

Jean_B

Trusted Information Resource
#19
I think there is a lack of distinction between compliance auditing (external certification and some internal audits), adherence & operational auditing (should be in internal audits) and improvement audits.
John Broomfield's comments feel more like the latter two, and do add value beyond the limited intent of focused regulations.
I often dislike an antagonistic attitude but it is necessary when auditors overstep the scope of their audits or the nature of the finding transforms from a requirement not being met to it not being met in the way they (or the auditing organisations' internal policies) see fit. However, there are audits which are not for certification but for improvement with best practice. There it is not about what any law (directly or indirectly) says you must do, but what is wise to do as indicated through an auditor who has seen many types of organisations through many phases of growth. There the auditor selected by management is chosen based on trust in value they might bring, which is a rather different relation to the auditor forced on you because of (mandatory) certification.
 

John Broomfield

Staff member
Super Moderator
#20
Ronen,

I’ve not enough evidence yet to report a nonconformity.

But, for a high risk business, I’d still want to interview top management about their ultimate risk management tool: liability insurance.

Your CB as audit client may not permit that but the case below suggests they would not want to ignore the full extent of risk management:

PIP breast implants: French court tells TUV to pay damages New damages ruling on PIP breast implants

Above case may show the importance of liability insurance for all involved.

John
 
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