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We know that the next-generation MDD, 2007/47/EC, will include a clarification (which for many device makers will amount to a change from the prior-assumed meaning) to the effect that all medical devices should include a clinical evaluation in their technical file.
We also know that the FDA is currently asking for comments on the Global Harmonization Task Force (GHTF) Study Group 5's draft document "Clinical Investigations".
Do these two regulatory-evolutionary changes head in the same direction? Will compliance with 2007/47/EC position us to not have to make further changes to comply with future FDA regulations if those regs are modeled on the current GHTF draft?
We also know that the FDA is currently asking for comments on the Global Harmonization Task Force (GHTF) Study Group 5's draft document "Clinical Investigations".
Do these two regulatory-evolutionary changes head in the same direction? Will compliance with 2007/47/EC position us to not have to make further changes to comply with future FDA regulations if those regs are modeled on the current GHTF draft?