Hello Chris,
The designation of the Person Responsible for Regulatory Compliance (PRRC) should be top management as would be expected for other roles within an organisation. Often there is an "appointment letter" created though this is not required. It is not a requirement, but unfortunately this becomes commonly requested to show how a person is appointed. Make sure to read MDCG 2019-7 as there are some nice information in there about where this person should be, their roles, responsibilities, and qualification for this position.
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Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 12-Jun-2022 17:14
From: Dan O'Leary
Subject: PRRC DESIGNATION in US
In any regulatory region, Top Management, as defined in EN ISO 13485:2016/A11:2021 should appoint and document the PRRC.
Consider this as an activity similar to appointing the Management Representative.
In both cases, the role is usually a collateral duty rather than a full time position. Typically, the Quality Manager has both collateral duties, but that is not a requirement.
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Dan O'Leary CQA, CQE
Swanzey NH
United States
Original Message:
Sent: 12-Jun-2022 16:20
From: Christopher Chin
Subject: PRRC DESIGNATION in US
Based on EU MDR, who has the authority in a US medical device manufacturer to appoint a Person Responsible for Regulatory Compliance?