Hello Anon,
I have to agree with ZIllery, the questions you are asking are quite broad in scope and difficult to answer in a forum post. In relationship to Unique Device Identification (UDI), this is where RFID is often used for the traceability and commonly referred to as Automatic Identification and Data Capture (AIDC). If using AIDC methods, these need to be defined in the quality system, manufacturing process, how they are verified, how they are validated, and checked (often in relation to UDI).
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Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 09-May-2022 10:21
From: Zillery Fortner
Subject: RFID tagged products - regulatory framework EU & US
Hello,
I would be glad to answer some questions but I want to make sure I am clear on what is your ask. I came from a company that used RFID tags/chips in its reusable products.
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Zillery Fortner
Product Advisor QA/RA Life Science
Hamilton NJ
United States
Original Message:
Sent: 09-May-2022 09:04
From: Anonymous Member
Subject: RFID tagged products - regulatory framework EU & US
This message was posted by a user wishing to remain anonymous
Dear Community,
I would like to benefit from your experience.
Did you have any insights to share on regulatory framework (EU & US) applying to RFID tagged product?
- I have identified few regulation / directive (RED, ecodesign, WEEE, 94/62/CE, CONEG... ) I would be interested in having your feedback in regards to applicability of these to an RFID Tagged product
- Do not hesitate to shared any other relevant requirements / sources of information I may have missed
- Also I am not clear on whether a CE marked is mandatory for the RFID tag itself (if yes, where is it defined?) & what is compulsory for the final tagged product
Your help would be highly appreciated !
Thanks in advance !