Italy Implements New Regulations, Requires Disclosure of Latex

The device industry is concerned that a new decree in Italy requiring the disclosure of latex in devices could catch on across the EU, creating an added burden for manufacturers. The decree, which took effect last month, also requires devicemakers to declare if latex is present in their packaging. And makers of certain devices must list on a database the materials in the devices that come into contact with patients. Unique to Italy, the latex requirement goes beyond those of the EU’s Medical Device Directives, Dario Pirovano, consultant on regulatory affairs at Eucomed, said.
International Medical Device Regulatory Monitor