. . . AMDR does not believe the additional specific requirements outlined in paragraph 31.11
are necessary. However, if maintained, AMDR urges MHRA to:
Strike 31.11(b)(i) on contract requirements; and Include remanufactured SUDs in the future exemption list (31.11(c)(ii)). We urge that 31.11(b)(i), that a “contract [be] in place with the manufacturer to allow them full access to the technical documentation for the medical device,” be stricken. Instead, we urge MHRA simply require that any manufacturer seeking to demonstrate equivalence under this subsection must, “demonstrate with satisfactory data used against industry standards, or by contract with the original manufacture or other means, knowledge of the material composition and construction of a device, and proving equivalent functionality with the predicate device, on an ongoing basis.” . . .
Click Here for AMDR’s full comments.
