Dear Pomme
I assuming that I am in a different position since I am an employee with MedTechXperts, not a legal manufacturer.
Since my business, MedTechXperts offers consulting services, including supporting the PRRC position, we were advised by a lawyer to have liability insurance which would cover this role. Other consulting firms have informed that they have also taken liability insurance to cover this role, PRRC.
In terms of liability protection as an employee of a legal manufacturer in the PRRC role, this is not as clear. In contrast to Markus report, the meetings that I have attended there were lots of discussions with no clear conclusions.
As a lay person, having taken 2 civil law classes (Canadian) in university, having no law degree, these are my assumptions. They need to be confirmed by a legal expert, a lawyer.
I believe that the company could hold an employee acting as PRRC liable if they have not fulfilled their position according the detailed PRRC description given in MDR Article 15 (3) and the company may be considered liable if it has not ensured that the PRRC has fulfilled the detailed description according to MDR Article 15.
Interestingly, the MDR Article 15 states that: "person responsible for regulatory compliance shall suffer no disadvantage within the manufacturer's organisation in relation to the proper fulfilment of his or her duties, regardless of whether or not they are employees of the organisation".
In terms of your other questions, consultation with legal experts (Swiss lawyers) may be a better route.
Best Regards,
Stephanie
MedTechXperts GmbH
Jungenbergstrasse 7
CH-5023 Biberstein
Switzerland
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Stephanie Grassmann
Managing Director of MedTechXperts Ltd
Biberstein
Switzerland
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Original Message:
Sent: 27-Nov-2020 05:52
From: Pomme Boissier
Subject: PRRC Insurance Coverage
Dear all,
If the MDR does not consider personal liability, some national law do. I heard that PRRC may be considered liable at individual level in some countries.
Does anyone knows what is the position of Switzerland ? and what about other countries ? where could I find the information .
Best Regards
Pomme
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Pomme Boissier
QA RA Manager
Neuchatel
Switzerland
Original Message:
Sent: 03-Nov-2020 04:36
From: Markus Lantermann
Subject: PRRC Insurance Coverage
Hey Stephanie,
please consider that there is no personal liability described in the MDR/IVDR for the PRRC. This was also confirmed on several conferences and by external and internal legal assessments. The MDR speaks about insurance regarding the company but not for the individual. So from my perspective an insurance is not required for the PRRC (but you need to provide evidence for liability backups for the legal entity in case your products has caused harm).
All the Best
Markus
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Markus Lantermann
Head of Q&R Region International
Mannheim
Germany
Original Message:
Sent: 01-Nov-2020 13:01
From: Stephanie Grassmann
Subject: PRRC Insurance Coverage
Dear Members
I am looking for insurance companies providing insurance to cover the PRRC role, as described in the EU Medical Device Regulation (MDR). At this point of time, I have only found one insurance provider, which we have been using since 2016. Now, the policy is coming up for renewal.
Does anyone know of other companies offering insurance policies to cover the MDR PRRC role? Any recommendations would be great.
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Stephanie Grassmann
Managing Director of MedTechXperts Ltd
Biberstein
Switzerland
http://www.medtechxperts.com
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