One of the important points that a medical device professional encounters is this: the technical file vs design dossier. The reason for the confusion about these two is that there are different names of the same concept and vary according to the class of device and the Notified Body that approves it. This is what has given rise to the technical file vs design dossier.
Depends on class of device
At a basic level, there is a difference between the two: the medical device manufacturer must have technical documentation for each device. Called the conformity assessment annex of the MDD, IVD and AIMD directives; this is a basic requirement of these regulatory bodies and statues. The important element of the technical file vs design dossier aspect is that the terminology technical file/design dossier sometimes varies depending on whom the directive has come from, and the annex in which it is placed. This is why there is some confusion on this technical file vs design dossier matter.
The two terms are interrelated
The following description should give a perspective: by the term “technical file” is meant the description of the documentation that demonstrates the ways by which the device complies with essential requirements. Among these devices, some devices require a design examination. The Technical Construction File (TCF) of such devices is called a design dossier. This explains the fundamentals of the technical file vs design dossier debate.
Depends on the Notified Body
To recap, the technical file, which the MDD refers to as “technical documentation”, is a bunch of documents that the medical device manufacturer has to put in place and furnish to their Notified Body for assessment. This is to show that the medical device conforms to the Essential Requirements of the directive. While this much is clear, some Notified Bodies require different methods of documentation for certain class of medical devices. These are to be presented as a design dossier. This is what has given rise to some confusion about the technical file vs design dossier issue.
Reference:
http://www.tuvamerica.com/tuvnews/newsletters/searchdetail.cfm?ID=552
http://elsmar.com/Forums/showthread.php?t=28968
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I wish I’d read this before my recent MRI. I might have asked about “the technical file vs design dossier issue.”
I appreciate your looking into the pharmaceutical industry. I’m in it as one of those poor fools who developed a condition.
Food for thought. Thanks for the like.
Thanks to both of you, Paula and Alan!
Human whole of person needs are so vital to the successful outcome of any medical procedure. Thank you for this article. I have a pace maker to help with a medical condition with the intention of preventing the minor from becoming the major. I am very grateful for the information I was given but I do like the reference here to the technical file vs design dossier issue. For me this had to be basic, functional and ‘about me’ not about what was design dossier or ‘world-wide’ trendy. Peace as a person – the inner powerful component for quality of life and my functioning purpose in life had to be addressed. As an older person now, I appreciate all information as spelt out in the article. Thank you. .
Thank you for your very kind words, Faye. Cannot agree with you more. Nothing matters as much as inner peace, as you say. Tried meditation techniques?
You have our hearty wishes for a healthy life ahead.
Interesting and informative. Thanks!
Thank you, Stephanie! Glad you like our post.