MDSS EUROPEAN AUTHORIZED REPRESENTATIVE SERVICES MDSS CONSULTING   ENGLISH    GERMAN    CHINESE
News Updates
  • Looking for a suitable GMDN-Code?
    MDSS can assist you to determine an appropriate code for your products!
    more


  • MDSS, may support you with the process of applying for a Free Sales Certificate/Certificate of Marketability...
    more


    
HIGHLIGHTS
Keep up to date!

THE "NEW CE MARKING"
Get your questions answered for the NEW REGULATION 
– THE MDR/IVDR!!!

more...


In-House Workshops
The "NEW CE MARKING"
Book now
 to make sure you’re ready to survive and thrive!



Cosmetic Products in Europe

Latest News




EVENTS
Join us!

RAPS EU MDR / IVDR Workshop
May 16 & 17, 2018
Brussels, Belgium



MDSS Roadshow
- the “NEW CE Marking” -
‚Äč
  • May 03, 2018, Milton, MA, USA
  • July 27, 2018, Chicago, IL, USA
  • August 03, 2018, Chicago, IL, USA 



Meet us!


AACC Clinical Lab Expo
July 31-02 August, 2018
Chicago, USA
Booth #4052




CONTACT

MDSS GmbH
Schiffgraben 41
30175 Hannover
Germany

Phone
(+49)-511-6262 8630
FAX
(+49) -511-6262 8633

Click here to
contact us





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.

BACK TO OVERVIEW