Maybe not an answer, but maybe helpful.
See below the definition of 'Organization' from ISO 9000:2015, which provides the definitions used in ISO 13485, against which the requirements could be assessed by an auditing organisation.
3.2.1
organization
person or group of people that has its own functions with responsibilities, authorities and relationships
to achieve its objectives (3.7.1)
Note 1 to entry: The concept of organization includes, but is not limited to, sole-trader, company, corporation,
firm, enterprise, authority, partnership, association (3.2.8), charity or institution, or part or combination thereof,
whether incorporated or not, public or private.
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Edward Staunton
Glasgow
United Kingdom
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Original Message:
Sent: 25-May-2022 11:44
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 the Person responsible for regulatory compliance as referred in 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 available a PRRC which is an employee of the manufacturer parent company which holds 100% of the manufacturer company, would the manufacturer comply with the requirement "within their organisation" set out in art. 15 MDR?
Many thanks