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News and Views March 2017

New Medical Device Regulation (MDR) in Europe

In-House Workshops
The "NEW CE" mark
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to make sure you’re ready to survive and thrive

Meet us!

8. Medical Device Networking Meeting
Hanover, April 27, 2017

Contact MDSS

Schiffgraben 41
30175 Hannover

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

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MDSS Sales Certificate Services

Free Sales Certificate / Certificate of Marketability

Have MDSS, your Authorized Representative (AR), apply for a Free Sales Certificate/Certificate of Marketability on your behalf

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 the penetration to non-EU markets a Free 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 are needed:
  • Product names and/or model/part numbers

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

MDSS as your Authorized Representative may obtain a Free Sales Certificate for any non European  country. MDSS currently implemented a fast process for the following countries:

Algeria, Argentina, Bolivia, Brazil, Cambodia, Chile, China, Colombia, Costa Rica, Ecuador, Egypt, Guatemala, Hong Kong, India, Indonesia, Iran, Israel, Jordan, Kazakhstan, Morocco, Mexico, Nigeria, Panama, Paraguay, Peru, Philippines, Russia, Saudi Arabia, Serbia, Singapore, South Korea, Sri Lanka, Syria, Taiwan, Thailand,  United Arab Emirates, Uruguay,  Venezuela and Vietnam.

The identification of the country is important because often the certificate of Marketability has been issued by the Authority and various different requirements are imposed by the country in regards to the legalization (apostille, translation, certification by the consulate etc.) 

MDSS  is the expert on  all the various steps which need to be applied.  If you would like to apply for a Free Sales Certificate for a country not listed above let us know  and we will find out the requirements for it.

Medical Device Safety Service GmbH
Schiffgraben 41
30175 Hannover

Phone: +49 511 6262 8630
Fax: +49 511 6262 8633

Or Click here for Contact Form

If MDSS is not currently your Authorized Representative we offer the service of further legalization through consulates as well. Please contact us directly in this case.