Do Leica Biosystems products and systems for sample preparation classify as in-vitro diagnostic medical devices? FAQ Report The directive on in vitro medical devices has clarified the procedures to be followed for analytical instruments. After having consulted external experts, we can safely say that our current procedures will stand up to close examination by both the legislative authorities and our customers. All products in our portfolio with major influence on the diagnosis are classified as in vitro diagnostic. This is stated in the corresponding CE certificates.
				CE conformity declarations