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News and Views April 2012


3. Identification of manufacturers and authorized representatives on medical Devices


In our last newsletter we briefly discussed the CMC (Central Management Committee (http://www.cmc-md.eu/)).  We provided you with their decision in regards to the disclosure of the address.  For reference the decision can be found here:

http://www.cmc-md.eu/mediapool/97/978504/data/Decision_3_update-16thJuly.pdf


These decisions are now being implemented in national surveillance activities.  For example the Swiss authority published on its website a document which can be found here:

http://www.swissmedic.ch/marktueberwachung/00170/00904/index.html?lang=en


Please scroll down the page and below 12-2011 you will find the pdf.  On the document it is stated: "
Against this background, the addresses stated on medical devices in Europe will be checked for completeness as of September 20124. The competent authorities may then initiate surveillance procedures with regard to companies that do not fulfill this requirement:"


Here you find other decisions the CMC published: http://www.cmc-md.eu/decisions.html 

Please note a recent decision was published (dated March 14, 2012) on the Readability of the Instructions for Use.

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