European Medical Device Labeling

European Medical Device Labeling

How to define medical devices for in vitro diagnostic (IVD)? According to the Decree-Law n. 189/2 of 12 August, which transposes Directive 98/79/EC, DIV is: any medical device in vitro diagnostic which is a reagent, reagent product, calibrator, control material, assembly, instrument, apparatus, equipment or system whether used alone or in combination, intended by the manufacturer to be used in vitro analysis of samples from the human body with the [...]

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European Medical Devices Database

European Medical Devices Database

Austrian Medical Devices Registry Database for manufacturers (including manufacturers of custom-made devices) and importers of medical devices (including in vitro diagnostics) and Their Authorized Representatives as well as Notified Bodies, ie, auditors and certifiers. Under the Austrian Act on Medical Devices and so under European directives Concerning medical devices and in vitro diagnostics, Austria is Obliged to maintain a registry of medical [...]

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European CE Mark Medical Devices

European CE Mark Medical Devices

CE marking for medical devices Medical devices (MD) are a group of very different products, ranging from consumables to large equipment: syringe, stethoscope, catheter, MRI (magnetic resonance imaging), Used both to diagnose disease (diagnosis), prevent its occurrence (prevention) or treatment effects (therapy), medical devices occupy an increasingly important role in the health sector. To move freely within the European Economic Area (EEA), medical [...]

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European Community Medical Devices

European Community Medical Devices

Borderline products The product term border en ) dsigne tout produit pour lequel il est difficile de dterminer le cadre rglementaire dont il relve. English (en) means any product for which it is difficult to determine the regulatory framework to which it belongs. These cases strongly concerned Member States, the Commission and other stakeholders, as they give rise to different interpretations within the Community and are therefore likely to endanger [...]

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European Medical Device Registry

European Medical Device Registry

Last updated: 13/03/2012 Manufacturers of medical devices based in Spain, which put on the market products of class I and customized products (including active implantable medical devices). Groupers of medical devices bearing the CE marking in accordance with their purpose and within the limits of use specified by their manufacturers, in order to put them on the market as systems, assemblies or equipment for medical or surgical procedures. Natural [...]

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European Medical Device Directory

European Medical Device Directory

Terms of marketing - The main principles of the CE marking A product that meets the definition of a medical device (DM) must be CE marked under the European Directive 93/42/EEC. Other guidelines exist for active implantable medical devices (Directive 90/385/EEC) and medical devices in vitro diagnostic (Directive 98/79/EC). To be placed on the market must have a DM met the requirements of the European Directive. The European Directive describes the [...]

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Medical devices in European

Medical devices in European

Class I (sterile / measuring), IIa class, IIb and class equipment manufacturers, use the CE mark and launch products on the market before, must be based Notified Body CE Marking Directive 93/42/EEC obtain verification. In order for your organization to get the CE mark verification, according to the combination of products including drug paraphernalia, all equipment Directive 93/42/EEC and Directives 2003/32/EC (animal tissue), 2005/50/EC (artificial [...]

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European Medical devices Magazine

European Medical devices Magazine

SUMMARY This Directive applies to medical devices * and accessories * . It does not apply to: the devices for in vitro diagnosis ; to active implantable devices ; to medicinal products for human use , including blood derivatives; with cosmetics ; partially human blood , the blood products , plasma or blood cells of human origin or to devices which incorporate at the time of placing on the market such blood products, plasma or blood cells in the exception [...]

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