I agree with the analysis and approach of Dan. The AR is an important party in the regulatory chain of EU compliance and suitable controls are needed.
I would like to add that when the activities of the AR are considered to be outsourced processes, these processes should be taken into account in the internal audit program. How often and how the audits should be performed is part of the audit program; remote is a possible consideration and also a document review of the associated procedures of the QMS of the AR, etc.. This is why I am very cautious to identify these activities as outsourced processes. One can even extend this discussion to distributors who sell the medical devices on the market on behalf of the manufacturer and consider these activities as outsourced processes....
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Peter Reijntjes
Principal Consultant Regulatory & Quality Affairs
Arnhem
Netherlands
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Original Message:
Sent: 09-Jan-2020 11:08
From: Jackie Torfin
Subject: Supplier audit of EC Rep - MDR
While I don't disagree with Dan, I would say that the need for an in person visit/audit is a little dependent on the ability to have clear communication and understanding of the responsibilities and ongoing interactions you will have. Sometimes - the language barrier can daunting, and there is no substitute for a meet and greet in person to truly obtain joint understanding.
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Jackie Torfin
Vice President, Global QA and Regulatory Compliance
Maple Grove MN
United States
Original Message:
Sent: 09-Jan-2020 11:03
From: Dan O'Leary
Subject: Supplier audit of EC Rep - MDR
The authorized rep is a supplier that provides a service to the manufacturer. The service is an outsourced process.
Manage the supplier following ISO 13485:2016 Clause 7.4. Also, since this is an outsourced process, follow ISO 13485:2016 Clause 4.1.5. Be very careful with the quality agreement. Read the ISO 13485:2016 Handbook discussion. The mandate is the quality agreement, so you do not need a separate document. Be sure to clarify this point in the supplier file.
Be careful with classifying suppliers as critical or crucial, since that can trigger NB unannounced audits. There are no standard definitions, so be sure to get your NB's definitions and classify your suppliers.
ISO 13485:2016 never requires an audit, but in some cases it is useful. You will need to determine the value compared to expense. In my view you do not need an on-site audit. The authorized rep is just an office, and there will be nothing to see.
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Dan O'Leary CQA, CQE
Swanzey NH
United States
Original Message:
Sent: 09-Jan-2020 10:11
From: Anonymous Member
Subject: Supplier audit of EC Rep - MDR
This message was posted by a user wishing to remain anonymous
Hi,
As the EC Rep is a crucial supplier to the manufacturer - my question is what is the best practice for supplier management of EC Rep?
Does conducting an initial assessment and maintaining the mandate deemed sufficient? or a supplier audit is needed for the EC Rep? Any thoughts?
Thanks in advance!