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News and Views March 2017

New Medical Device Regulation (MDR) in Europe

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

Meet us!

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


Schiffgraben 41
30175 Hannover

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

Click here to
contact us

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 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.

If MDSS is not your Authorized Representative we can support you with implementing and processing of the application to obtain a Free Sales Certificate.  MDSS offers support with each step of the specific requirements for example the further legalization of the document with the appropriate consulate. if you would like to receive further information regarding this scope of our service please feel free to contact s directly thorugh our contact form.

MDSS has practical knowledge on the process of obtaining Certificates 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
MDSS Consultancy Division
Schiffgraben 41
30175 Hannover

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

Or Click here for Contact Form