CENTRO DI DOCUMENTAZIONE SUI DISPOSITIVI MEDICI

From website The European Commission provides a range of guidance documents to assist stakeholders in implementing directives related to medical devices. Guidance MEDDEVEs The MEDDEVs promote a common approach to be followed by manufacturers and Notified Bodies that are involved in conformity assessment procedures. The MEDDEVs are drafted by authorities charged with safeguarding public health in conjunction with all stakeholders; industry associations, health professionals associations, Notified Bodies and European Standardisation Organisations. This is in accordance with the relevant annexes of the directives MEDDEVs are carefully drafted through a consultation process with all interested parties and are subject to a regular updating process These documents have particular reference codes and are endorsed at the Medical Devices Expert Group (MDEG) plenary meetings The guidelines are not legally binding. However, due to the participation of the aforementi...

Many products require CE marking before they can be sold in the  EEA  ( EU + Iceland, Lichtenstein and Norway). CE marking proves that your product had been assessed and meets EU safety, health and environmental protection requirements. It is valid for products manufactured both inside and outside the EEA, that are then marketed inside the EEA. To affix the CE marking to your product, you must put together a technical dossier proving that your product fulfils all the EU-wide requirements. As the product's manufacturer, you bear sole responsibility for declaring conformity with all requirements. Once your product bears the CE marking, you might have to provide your distributors and/or importers with all the supporting documentation concerning CE marking. More information>Click Here