European Medical devices symbols

Greece Sees Rise in HIV Infections

03 May. 2013

Identification of medical devices and medicinal products subject to special monitoring

The month of March was published Regulation (EU) No 198/2013 on the new identification symbol shall incorporate the drugs whose authorization is subject to additional monitoring. Publication that has followed, just a month later, the Commission Recommendation of April 5, 2013, by which it seeks to foster a unique identification system for medical devices across the EU. For your interest, we will briefly discuss its highlights.

Identification of medicinal products subject to special monitoring

So that can be easily identified by healthcare professionals and patients, the drugs subject to additional monitoring because of its unique safety profile, which include biological, those containing a new active, and those who are requires the completion of post-authorization-shall incorporate an inverted equilateral triangle black.

The drugs concerned shall include this symbol in the SPC and package leaflet before December 31, 2013, but for products authorized before September 1, 2013 may request an extension of this period if there is a risk of generating situations shortages. In addition, laboratories will also continue to provide labeled and packaged units prior to January 1, 2014, but do not include the symbol, until stocks are exhausted.

Unique identification system for medical devices

Since the current European regulatory framework does not include provisions on traceability of medical devices, the Commission has sought to anticipate future regulation through recommendations intended to prevent manufacturers from being obliged to implement different systems for each country. These recommendations apply to all medical devices except custom-made, those for research and in vitro diagnostic products to assess the performance or manufactured in health centers.

The identification, according to the Commission, should include both the product identifier (manufacturer and model) as the production (production unit level traceability and risk-based), and, ideally, occur in both readable and electronic form. Such information should be stored by the various actors along the distribution chain, and used in reporting incidents. Finally, it invites Member States to promote the use of eXtensible Markup Language (XML) as the common format for data exchange.


rigjobsonline.com
2011-03-01 13:00:06 by csipodunk

McAfee/Intel

Would this indicate that a virus is capable of invading a processor? Other related links at the bottom of the full cnet article.
March 1, 2011 6:18 AM PST
Intel completes McAfee acquisition
by Lance Whitney
Intel has completed its $7.68 billion acquisition of McAfee.
The completion of the deal, announced yesterday, follows approvals by the various boards of directors and stockholders, as well as reviews by the Federal Trade Commission, the European Commission, and other regulatory groups

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