Sgs Achieves a Full Ivdd Notified Body Scope (2011-03-23)
SGS has extended its Notified Body scope under the European Directive 98/79/EC on in vitro diagnostic (IVD) medical devices to include high risk LIST A products, giving a full designation scope. SGS initially gained designation as IVD medical device Directive (IVDD) Notified Body 0120 in 2010, with a scope that included all LIST B and Self-Test IVD devices. The extension means that SGS Notified Body can additionally provide certification services for all LIST A devices. SGS now has a global comprehensive scope for all manufacturers of IVD devices.