Dear Ed and All,
The liability concerns is an interesting topic in particular for the EC REP since he being stated as liable as well.
I like to start with common sense. The liability concerns were always with the owner(s) of the company or are simply good business practice. With the MDR the liability concerns have reached the regulatory department.
In general, and I believe this is most likely true for all countries, that consumers should be protected and if they experience damage from someone then they should be compensated for it. This applies certainly also between two natural persons.
In Europe we have a liability regime clarifying this further. For example, compensation cannot be sought forever etc. In general, the Manufacturer or the Importer are liable. The distributor may be liable but if he can point to the manufacturer or the Importer, he is off the hook. Please have this general statement verified with the actual liability regulation.
We also may have to recognize that the means of compensation is not stipulated. To have an insurance is not mandated. However, please be careful this may indeed be mandatory in some countries. For example, for clinical studies in Germany, a specific coverage is required and with that the patient cannot ask for more.
Let's look at the different objective and how they go hand in hand.
The owner of the company has the goal to protect his company in case his products would be the cause of any liability issue. The regulatory department has received a different objective by the MDR regulation, which is to protect the patient. Different objectives but it should lead to the same result. An insurance may be the appropriate means for those objectives. The liability insurance indeed protects the company and the patients have been compensated as required.
The reason for the MDR liability article was also due to the medical devices scandals in Europe. Some of you may remember the PIP case but that was not the only one. With the PIP case the company was quickly dissolved and as soon the owner admitted fraud the insurance did not have to pay since fraud is not insured.
We as EC REP certainly may rely on the manufacturers insurance since the patient does not need to be compensated twice. Once is enough. It is also difficult to understand that the EC REP was being brought into the liability regime. A general principle of liability is that you would have to handle the products. Most certainly the EC REP is liable as anyone else for his services.
The MDR gives "clear instruction" for the manufacturer on how to evaluate the means of compensation for the patients. Each point should be fully evaluated and addressed accordingly with a liability risk evaluation. The insurance company certainly may be helpful doing this.
This is long statement for outlining that your company should be OK with the current liability since someone may safely assume that the owner has done a good job to protect his company. However, since it is a requirement of the MDR the regulatory department should indeed verify with the above indicated risk assessment whether indeed the insurance and other resources are sufficient.
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Ludger Moeller
President, MDSS GmbH
l.moeller@mdssar.com------------------------------
Original Message:
Sent: 23-Jun-2021 09:03
From: Ed Panek
Subject: MDR Liability Insurance
Thanks all!
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Edward Panek
VP, QA/RA
Med Device
USN Veteran
Research into Neural Nets - https://www.twitch.tv/edosani
Original Message:
Sent: 23-Jun-2021 04:47
From: Markus Lantermann
Subject: MDR Liability Insurance
Hi Ed,
nothing more significant to add, however, I would make sure that the value of the insurance is still state-of-the-art. This may depend on potential reclassifications of your devices (higher risks may justify a higher coverage). Usually, this is nothing that the Notified Body will check during their conformity assessments, however and despite a legal assessment, they could provide a few insights from their experience with manufacturers of comparable products.
Hope this helps - All the Best
Markus
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Markus Lantermann
Head of Q&R Region International
Mannheim
Germany
Original Message:
Sent: 22-Jun-2021 15:03
From: Ed Panek
Subject: MDR Liability Insurance
"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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Edward Panek
VP, QA/RA
Med Device
USN Veteran
Research into Neural Nets - https://www.twitch.tv/edosani
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