GHTF consults on deleting "type examination" option from its revised conformity assessment guideline
This article was originally published in SRA
The Global Harmonization Task Force is seeking feedback on proposed revisions to its guideline on principles of conformity assessment for medical devices. Among other things, comments are being sought on whether the guideline should remove the option of using a "type examination" procedure to demonstrate compliance with the relevant essential principles of safety and performance1,2.
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