Hello Anon,
As with many regulations unfortunately even a single or few words can be interpreted different ways. From my reading, the first intent is the Person Responsible for Regulatory Compliance (PRRC) is an employee of the company and not outsourced. Because then this individual has a vested interest in what happens within the company, compliance of product, and maintaining the quality system. The second intent, as Erik indicated, if the organisation is a multi-national company than this person could be at another site or even different group within the company. But could this be a person at a sister company with different QMS or does it have to be the same QMS? Probably the later. Again, it has to do with the person being "responsible" for the product compliance and QMS. Under the Article there is also the allowance if the company is small or micro, this can be outsourced.
Also note this person must be qualified in this role as well according to the Article. The recommendation would be whatever way the company complies with Article 15 or who they designate as the PRRC the reasoning behind this should be defined somewhere - of course if it is not straight forward. If a company decides the Director of Regulatory Affairs who is responsible for three (3) different sites (based in say United Kingdom) needs to clearly define how this is, why this is, and how Article 15 is met for each of the medical device manufacturing sites - or if it one under the same QMS. This is where the proverbial "appointment letter" for a Management Representative (MR) or PRRC has come into existence to clearly define who is the PRRC (or MR) when it is not clear within the organisation. So to answer your question, yes I would think so, just recommend detailing in a document somewhere how this is done and why it is being done that way, i.e. the person at the parent company is qualified, no one at the manufacturer can do this role, same company, etc.
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Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 26-May-2022 04:35
From: Erik Vollebregt
Subject: PRRC art. 15 MDR - "within the organisation" requirement
Strangely enough the MDR does not define the concept of organisation and only refers to this in recital 34, not giving any details on what the scope of the 'manufacturer's organisation' is. My interpretation is that it concerns the scope of the manufacturer's QMS for the device concerned. If the parent company is in scope of that, then the requirement is met I think. If not, it is not met.
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Erik Vollebregt
Partner
Amsterdam
Netherlands
Original Message:
Sent: 25-May-2022 11:59
From: Anonymous Member
Subject: PRRC art. 15 MDR - "within the organisation" requirement
This message was posted by a user wishing to remain anonymous
Hello everyone,
I have a question about art. 15 MDR.
Taking into consideration that
- art. 15 MDR states
"Manufacturers shall have available within their organisation at least one person responsible for regulatory compliance..." - MDCG 2019-7 states
"The person responsible for regulatory compliance (PRRC) appointed would need to be an employee of the organisation."
If a manufacturer has at his disposal a PRRC that is an employee of the manufacturer parent company that holds 100% of the manufacturer company, would the requirement "within their organisation" be complied?
Many thanks