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EU MDR

Is Your Medical Device a Well-Established Technology (WET)?

As guidance committees, manufacturers, and notified bodies continue to interpret the EU MDR, some areas remain fuzzy. Well-established technology (WET) is high on the list of definitions that are disputed as notified bodies seem to have a different interpretation than the guidance document. This puts manufacturers in the difficult position of having to decide whether a device is a WET and defending that stance to notified bodies.
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