European Agency Medical devices

Meanwhile, the European Space Agency (ESA) has developed

Friday, 3 May 2013 Witten / Herdecke - Scientists from across Europe, led by Edmund Neugebauer of the University of Witten / Herdecke a petition submitted to the European Commission, the European Parliament and the European Council. With it they want to deficiencies in the Medical Device Directive (Medical Device Directive) point. The Directive is currently being revised to improve the admission and use of medical devices in order to increase safety and protection for patients.

According to experts, the proposed revision of the European Commission, however, is not enough. The scientists criticized, among other things, that no evidence of market access will be required for the clinical and patient-relevant benefits and approval processes are not transparent.

Centralized marketing authorization necessary
"We therefore call for a centralized marketing authorization of medicinal products with medium and high risk (Class IIb products and III) as well as in-vitro diagnostics, which is done by a public institution comparable to the European Medicines Agency or by an extended mandate of the Food and Drug Administration" , it is stated in the petition.

At the same time, scientists are asking to increase patient safety in the short and long term through scientifically sound evaluation of clinical and patient-relevant benefits and side effects. In addition to all the information in the future from the certification process, including the decision basis for the certification of medical devices and in vitro diagnostic medical devices available on a public website, regardless of the risk class, to be published. ©hil / aerzteblatt.de

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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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