MDR/IVDR Certificate of free sale

Most of countries shall ask Certificate of Free Sale. This certificate is used for exporting the goods to another country.

Manufacturer or an authorised representative may request the Member State in which the manufacturer or the authorised representative has its registered place of business.

Certificate of free sale shall declare that the manufacturer or the authorised representative, as applicable, has its registered place of business on its territory and that the device in question bearing the CE marking in accordance with this MDR/IVDR may be marketed in the Union.

Certificate of free sale include ,

• Basic UDI-DI of the device as provided to the UDI database under  MDR Article 29/IVDR Article 26.
• Unique number identifying the certificate issued by the notified body per Section 3 of Chapter II of Annex XII (Certificate of Conformity)

 Commission may, by means of implementing acts will provide  a model for certificates of free sale.

Source :

REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC

REGULATION (EU) 2017/746 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU