Not knowing the answer to the question posed in the title of this article has led many medical device manufacturers to undertake expensive and unnecessary retesting of their previously certified products.

In Annex 1 of the “Medical Device Directive 93/42/EEC—Essential Requirements—Section 2,” the directive states, “The solutions adopted by the manufacturer for the design and construction of the devices must conform to safety principles, taking account of the generally acknowledged state of the art.”

But what is “state of the art?” Many companies were mistakenly told that “state of the art” meant using the latest standards. Even though most of their devices had a perfect safety record and exemplary records of clinical performance, they were expected to meet newer, basic safety standards, including IEC 60601-1 3rd edition. Incidentally, this was done despite frequent notice from the European Commission to Notified Bodies that such an interpretation of “state of the art” was incorrect.

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