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CE Tech File Review/Update

By Richard Fullenkamp posted 24-Jun-2014 08:05

  
You may want to consider an Annual Product Review - which is kind of like a Management Review for a particular product. Once a year you review the product from incoming inspection to complaints. An output of the review (among others) is updating of the CE file.
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Thomas Navarro
22-Jul-2014 13:16

An Annual Product Review is similar to compliance for annual reporting; however, a best practice (from a regulatory perspective) is to be cognizant of all changes that may impact a product DURING the follow-up period. I have found myself conducting regulatory assessments in real-time to indicate whether the design, manufacturing or labeling change affects my Technical Files, and then updating the TFs depending upon either "significant" or "non-significant" determinations and (of course) the Notified Body decision. Being pro-active and preparation is the best tool to use in this situation.