European Medical Device Registry

EORNA

Last updated: 13/03/2012

  1. Manufacturers of medical devices based in Spain, which put on the market products of class I and customized products (including active implantable medical devices).
  2. 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.
  3. Natural or legal person who sterilized for placing on the market systems, assemblies or equipment for medical or surgical procedures, and other products bearing the CE marking and have been designed by their manufacturers to be sterilized before use.
  4. Manufacturers of medical devices for in vitro diagnosis, established in Spain, who market these products in their own name.
  5. Authorized representatives established in Spain to put on the market or market the products mentioned in the previous sections.

This application complies with the provisions of Article 24 of Royal Decree 1591/2009 of 16 October, by which regulates medical devices, Article 14 of Royal Decree 1616/2009 of 26 October, regulating the active implantable medical devices, and Article 9 of Royal Decree 1662/2000 of September 29 on medical devices in vitro diagnostics.

In order to standardize on a single database Registry Responsible for placing on the market of medical devices for active implantable medical devices and in vitro diagnostic intended, and to facilitate compliance with this legal requirement part of those in charge, has established a single application to make cash by filling in an electronic form.

Consequently, manufacturers and product representatives in vitro diagnostic medical devices may choose this path to register for the Record Responsible for placing on the market set the Competent Authority, being in this case exempted from making the communication required to effect in the Autonomous Community.

The Responsible Registry data will be transferred to the European Database EUDAMED from May 1, 2011, following the provisions of 2010/227/UE Commission Decision of 19 April 2010 on the basis European Data on medical devices (EUDAMED).

Medical devices placed on the market prior to 21/03/2010

To that medical devices placed on the market prior to 21/03/2010 can join the new registry Responsible created, is provided also in the same software application, an electronic form through which companies can communicate data voluntarily, in this way, it will have the responsibility and product data in a format suitable for subsequent transfer to the European base EUDAMED.

In order to meet the deadlines set out in Decision 2010/227/UE to transfer this data to the base EUDAMED, data shall be submitted prior to April 30, 2012.

To access the two forms of this application, you must meet two requirements:

  • The first step is to perform the access request to obtain a valid username and password.
  • The second is to make sure you have installed digital certificate valid and not revoked in the web browser that will be used to access the application.

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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