Regulatory Open Forum

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Hello Usha

It depends on what countries you're doing business in.

The term "PRRC" is usually associated with the European Union. If you're there, you will have listed your PRRC in EUDAMED, and that record will need updating.

If you have a Canadian MDEL, changes in the establishment representative need to be notified. See the instructions for submitting notifications in the guidance:  https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/establishment-licences/directives-guidance-documents-policies/guidance-medical-device-establishment-licensing-0016/document.html#a71

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Anne LeBlanc
United States
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Usha, 

To follow-up on Anne's response. If this is for EU MDR compliance, ensure that you notify your authorized representative (if you have one) as well as your importer (if you have one). Also, you will want to ensure your internal documentation is updated in full with the change in PRRC as this will certainly come up in audits. 

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Stephanie Christianson, PhD
Senior Regulatory Affairs Product Manager
Kimberly-Clark
Remote - Durham, NC
United States
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Usha,

The Person Responsible for Regulatory Compliance (PRRC) is a European Union only designation and term.  As mentioned there are some places where this needs to be informed and/or updated EUDAMED, Notified Body, Authorised Representative, etc.  As for other countries like Canada (and United States or Japan or Brazil) there are individual requirements for the regulatory contact in this countries as well which is usually through an establishment registration (like US FDA) or local representative/sponsor.

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Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 25-Mar-2023 01:33
From: Stephanie Christianson
Subject: PRRC Change

Usha, 

To follow-up on Anne's response. If this is for EU MDR compliance, ensure that you notify your authorized representative (if you have one) as well as your importer (if you have one). Also, you will want to ensure your internal documentation is updated in full with the change in PRRC as this will certainly come up in audits. 

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Stephanie Christianson, PhD
Senior Regulatory Affairs Product Manager
Kimberly-Clark
Remote - Durham, NC
United States