1 Amendments of Françoise GROSSETÊTE related to 2012/0267(COD)
Amendment 75 #
Proposal for a regulation
Recital 5
Recital 5
(5) There are specific features of in vitro diagnostic medical devices, in particular in terms of risk classification, conformity assessment procedures and clinical evidence, and of the in vitro diagnostic medical device sector which require the adoption of a specific legislation, distinct from the legislation on other medical devices, whereas the horizontal aspects common to both sectors should be aligned without compromising the need for innovation in the Union.