I realize I'm probably swimming against a strong current here, but...
With respect to CE Marking, there is no mention of a technical file in the Medical Device Directive, much less a requirement for maintaining one. The "technical file" is an old manufacturing concept and term, going back to at least the industrial heyday of World War II. Long before the MDD (or the European Union, for that matter), product manufacturers routinely kept "technical files' to support a vast range of products, from ships to planes to tractors. Technical files related to construction and public works are also maintained by urban planners and architects, to support their construction projects, a different type of "product."
The applicable NB-MED Recommendation (2.5.1) is not titled "Technical File," but "Technical Documentation," and uses the term "technical file" only twice. First, the term is included in the keywords, possibly because they thought that some companies would have trouble finding the guidance otherwise. Second, it is included in the Rationale and History section of the Recommendation, where it is noted that, at the 1999 NB-MED meeting in Brussels, the initial plan to develop a guidance for a "technical file" were scrapped because "not a technical file but a system/organisation of technical documentation is required."
Coincidentally, I joined a high-functioning Class III start-up a few months after the Brussels meeting. The QSM and design engineers came to me to discuss maintenance of the design dossiers. They noted that almost all the documentation cited in the current NB-MED Recommendation was maintained in Document Control, and asked me if I thought it would be necessary to maintain a separate design dossier. There was concern that this would lead to redundancy and confusion and create room for error if the documents didn't match up, and they couldn't see the point of maintaining essentially duplicate sets of documentation. Neither could I. On the contrary, I thought that the few documents that were part of the design dossier (eg, Declaration of Conformity) but were not current controlled should also be controlled, so that we could be assured that all the technical documentation to support our design dossiers were securely maintained.
My "design dossier" was simply lists of the documents in Document Control that supported each product. When a new document supporting a product was added to Document Control, I updated my list of design dossier documents available for the product. Because our Document Control process included an updated listing of all documents in Document Control and notifications each time a new document was added, these lists were easy to maintain. However, if I were to set this up today, I would probably include a field in the Document Control database that identified the product(s) each Controlled Document supported, not only for CE Marking, but also for FDA and other regulatory agencies, so that we could run the list (essentially the table of contents of the continuously maintained design dossier) automatically as needed, instead of me having to maintain it by hand.
Everyone was happy with this approach, including our notified body, but those were very early days in the life of the MDD. (Ours was the first design dossiers our notified body ever reviewed.) Later, the start-up fell victim to a change in the competitive environment, and I moved on to another area for almost a decade. Coming back into device regulatory affairs a few years ago, I was quite surprised to find that Regulatory was maintaining technical files and design dossiers. I'm still not clear why Regulatory feels the need to do this, unless perhaps it is because they lack confidence in their company's document control process. The same thing goes for the "periodic update" of these technical files and design dossiers. If all of the documentation needed to support the product is under document control, and therefore gets reliably updated on an ongoing basis, I'm not clear on the need for periodic updates, either.
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Julie Omohundro RAC
Durham NC
United States
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