European Community Medical Devices

Concept of intelligence © Orlando Florin Rosu - Fotolia

Borderline products

The product term border en ) désigne tout produit pour lequel il est difficile de déterminer le cadre réglementaire dont il relève. 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 public health as well as distortions of competition within the internal market .

Therefore, to ensure a consistent approach within the community, the Commission attempted to facilitate dialogue between the authorities compétenteset industry where divergent interpretations exist.

Reprocessing of medical devices

In order to ensure a high level of health protection, the Commission services are currently analyzing the issue of the reprocessing of medical devices within the Community.


Counterfeiting en ) de produits de santé est une préoccupation majeure et croissante, en raison des risques pour la santé et la sécurité des patients qu'elle présente. English (en) health products is a major and growing concern because of the risks to health and safety of patients it presents. To fight against this phenomenon, there are actions the community, regional and international levels in order to ensure the provision of authentic products to European citizens.


In order to improve the traceability of medical devices and patient safety at the global level, the EU is actively contributing to the development of the unique identification of medical devices globally or UDI (Unique Device Identification) en ) . English (en) .

2006-04-15 20:34:56 by merrimac

No it doesn't there is accurate non Lab versions

Cholestech LDX System, which carries the CE Mark for marketing of medical devices in the European Union, has been certified
by the United States Cholesterol Reference Method Laboratory Network (CRMLN), which validates that the system meets the gold standard for accuracy and reproducibility developed by the Centers for Disease Control and Prevention (CDC) for the measurement of total cholesterol and HDL cholesterol consistent with National Cholesterol Education Program (NCEP) analytical goals. The NCEP recommends that everyone over the age of 20, or more than 200 million Americans, should be screened for cholesterol.

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