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The EU's juggernaut rolls on
Is the European Union's IVD Directive just one big exercise in trade protectionism? Like it or not, that question provided at least part of the subtext of last November's Workshop on Measurement Traceability for Clinical Laboratory Testing and In Vitro Diagnostic Test Systems sponsored by the National Institute of Standards and Technology (NIST).
The issue of protectionism is not a new one for the IVD Directive. It has previously arisen because the directive permits the EU member states to require labeling in whatever languages they consider necessary for their market (notably, such permission is not granted in the EU's directives for active implantables or other medical devices). And it was raised again when the IVD Directive was enacted without the common technical specifications that it requires for some products, leaving those to be compiled after the fact by European committees (more about recently approved specifications in future issues).
But the trigger for NIST's involvement was the directive's requirement that the calibrators and controls used in IVDs be traceable to reference standards of a higher metrological order—in effect, to approved international standards that would most likely be supplied by national metrological institutes such as NIST. According to workshop co-chair William F. Koch, deputy director of NIST's chemical science and technology laboratory, "early drafts of those requirements would have made manufacturers reveal details of their biochemical formulations that they weren't even required to include in their patent applications." NIST cooperated with the European Diagnostic Manufacturers Association (Brussels) to bring about a scaling back of the requirements originally proposed for the directive. Even so, the requirement for calibration traceability remains in the directive, and even the scaled-back version could have a dramatic impact on the ways that IVD manufacturers develop and market their products.
This issue of IVD Technology presents several different views of the NIST workshop, beginning with the summary that leads off our industry news section. Among this issue's features is a version of the workshop presentation by Lothar Siekmann, of the University of Bonn, describing German practices relating to metrological traceability). And finally, in our Regulations and Standards section, Donald M. Powers places the recommendations of the NIST workshop into context. Several other papers from the workshop are scheduled to appear in future issues of IVD Technology.
Like many aspects of the IVD Directive, the exact workings of the calibration traceability requirements are still being figured out. But thanks to NIST's involvement, U.S. manufacturers have ample opportunity to weigh in on the issues at a time when their input can still make a difference.
Steve Halasey
