Medical devices in European Union

MAKO Surgical Corp

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;
  • 2007-05-05 13:46:52 by johnnybaby

    You are following Hitlers plan

    At this time then, the only alignments between Nazism and Catholicism were the Church’s perceived anti-Semitism and anti-communism, and an abhorrence of abortions by healthy pregnant German women (although Hitler did diverge from the Church once again in 1939 when he authorized the medical extermination of mentally and physically handicapped children). As the war progressed and the Wehrmacht gained control of large parts of the Soviet Union, the question of the suppressed Russian Orthodox Christian sects surfaced. Hitler’s response was to leave them to their own devices “so they can beat each others’ brains out with their crucifixes”

    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.

    2005-11-15 12:36:27 by -

    Suicides linked to Tamiflu - so is only weapon a

    Suicides linked to Tamiflu - so is only weapon against bird flu safe?European medicines regulators have ordered a safety check on Tamiflu after reports that two teenage boys died in Japan in apparent suicides after taking the anti-flu drug.
    The deaths have raised safety fears about the only treatment against a threatened pandemic of avian flu. The deaths are not linked and occurred a year apart.
    The Japanese health ministry issued a warning in June 2004 about psychological and neurological disorders linked with Tamiflu, with an instruction that doctors should be alerted - but no similar warning was issued in Europe and the UK

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    Transaction Publishers Medical Devices: European Union Policymaking and the Implementation of Health and Patient Safety in France
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    EU regulation of medical devices and pharmaceuticals in comparative perspective.(European Union)(Report): An article from: The Review of Policy Research
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    IOS Press Information and Communication Technologies for Active Ageing: Opportunities and Challenges for the European Union - Volume 23 Assistive Technology Research Series
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