Classification of Devices according to European Directives/Norms - CE mark

Our products, according to European Directives/Norms in force and to intended purpose, can be roughly classified as follows:

In Vitro Medical-Diagnostics Devices (IVD): reference is made to Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 as subsequently amended and supplemented.

By IVD it’s meant all Devices used for in vitro diagnostic tests of samples coming from human beings (veterinary samples excluded), included blood and donated tissues (it’s not allowed using IVD directly on the patient). Notified Body is not necessary and Declaration of Conformity will be issued directly by the Manufacturer (except for Devices whose purposes are self diagnostic tests where the Notified Body has to be applied).

Download Directive 98/79/EC

General Laboratory Use: those products, roughly, that are not destinated from the Manufacturer to contain directly a human sample for diagnostic tests. They are not CE marked.

Medical Devices (MD): reference is made to Directive 93/42/EC of the European Council of 14 June 1993, Directive 2007/47/CE of the European Parliament and of the Council of 5 September 2007 as subsequently amended and supplemented.

These Devices are destinated to be used directly on humans. MD are roughly divided into classes as follows:
Class I) Non invasive or short time invasive
Class IIa and IIb) Short time invasive for natural or surgical orifices (IIa) and long time invasive (IIb).
Class III) Long time invasive or active implantable medical devices.

Download Directive 93/42/EC – Download Directive 2007/47/CE

Personal Protective Equipment (PPE): reference is Regulation (EU) 2016/425 of the European Parliament and of the Council of 9 March 2016 as subsequently amended and supplemented. Moreover PPE have to conform to specific harmonized Norms. By IPD are meant all equipments that a worker has to wear in order to protect himself from any risks that could damage his safety or health during working hours. IPD can be divided into three categories, according to the risk type.

Medical-Surgical Instruments (Only for Italian Law): subject to D.P.R. n. 392/98 as subsequently amended and supplemented, they are those products used in medicine, zootechnics and agriculture (for example disinfectants, bactericides or germicides) that can be produced and introduced to the market after authorization of Ministry of Health that grants their efficacy, reliability and safety during use.