Fifty-two guidance documents on medical devices and diagnostics issued by regulatory authorities from around the world were added to Medtech Insight’sGuidance Tracker in the past month.
The updated tracker includes two new guidelines by the EU’s Medical Device Coordination Group on the regulation of so-called Annex XVI products for which a manufacturer claims only an aesthetic or another non-medical purpose but which are similar to medical devices in terms of functioning and risk profile
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