European Medical Device Labeling

Ask Dr. O | Medical Device Labeling Topics

How to define medical devices for in vitro diagnostic (IVD)?
According to the Decree-Law n. º 189/2000 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 purpose of providing information concerning the physiological or pathological condition, congenital anomalies, determine the safety and compatibility with potential recipients, or monitoring therapeutic measures;
  • container (s) specifically intended by the manufacturer to contain and preserve the samples from the human body and intended for in vitro diagnostic study;

Who controls medical devices placed on the market?
The National Competent Authority is acting on behalf of his government ensuring that EU directives are implemented in their country.
In this context, INFARMED, National Competent Authority for the area of ​​Medical Devices, should ensure that they meet the legal requirements without jeopardizing the health and safety of patients, users and third parties as set out in Directive 98/79/EC. National Competent Authority for the DIVs:
National Authority of Medicines and Health Products - INFARMED IP

What are the functions of the Competent Authority?
The functions of the Competent Authority for the area of ​​medical devices are as follows:

  • Adoption and publication of laws and regulations necessary for the implementation of the Directives;
  • Participation in the working groups of the European Union and the Standing Committees;
  • Resolution of conflicts between manufacturers and Notified Bodies;
  • Assessment of requirements for medical devices in vitro diagnostics in performance evaluation;
  • Assessment of notifications and record keeping for medical devices for in vitro diagnosis made in our territory;
  • Market knowledge and supervision, in post-marketing;
  • Directory of the European Medical Device & Biomaterials Industry
    Book (Elsevier Science Pub Co)
    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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