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  • Looking for a suitable GMDN-Code?
    MDSS can assist you to determine an appropriate code for your products!
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  • Have MDSS, your Authorized Representative, apply for a Free Sales Certificate/Certificate of Marketability on your behalf!
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"The NEW CE MARKING"
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Cosmetic Products in Europe

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MDSS Roadshow
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AACC Clinical Lab Expo
July 31-02 August, 2018
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MDSS GmbH
Schiffgraben 41
30175 Hannover
Germany

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

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Free Sales Certificate / Certificate of Marketability


MDSS offers support during the whole process of applying for a Free Sales Certificate /Certificate of Marketability. 


From the regulatory point of view, the requirements for the introduction of a medical device on the European market are fulfilled.  The CE mark is an indication to show conformity to all obligations for medical devices as required by the Medical Devices Directives.  With the CE mark in place your products can be legally marketed in Europe (precisely the EU, EEA and the few other countries having mutual recognition agreements  in place).

However, for entering non-EU marketsFree Sales Certificate must be provided by the manufacturer.  The Free Sales Certificate demonstrates from the government that you place products, legally with the CE mark on the European market.  

The European Free Sales Certificate (FSC) / Certificate of Marketability, is issued by the Competent Authority of the EU member state where the “manufacturer” in Europe or his Authorized Representative (EC REP)  has his registered place of business. If the manufacturer is not situated in Europe only the Authorized Representative is able to obtain the Free Sales Certificate on behalf of the manufacturer.

In order to obtain a Free Sales Certificate / Certificate of Marketability for MDD and IVD devices  the following information is needed: 
  • Product names and/or model/part numbers

  • The country you would like to apply for a Free Sales Certificate / Certificate of Marketability 


If you are a MDSS client click here.

If are not yet our client click here.