MDR - Chapter V - article 60
Original text
Expert opinion
Certificate of free sale
1. For the purpose of export and upon request by a manufacturer or an authorised representative, the Member State in which the manufacturer or the authorised representative has its registered place of business shall issue a certificate of free sale declaring 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 Regulation may be marketed in the Union. The certificate of free sale shall set out the Basic UDI-DI of the device as provided to the UDI database under Article 29. Where a notified body has issued a certificate pursuant to Article 56, the certificate of free sale shall set out the unique number identifying the certificate issued by the notified body, as referred to in Section 3 of Chapter II of Annex XII.
The certificate of free sales
For the sole purpose of export, a certificate for free sales needs to be issued by the Member State in which the requestor has its registered business office.
Requestors can only be either the legal manufacturer or the EC REP.
The certificate shall bear information on:
- the requestor has a registered place of business in the territory of the member state
- The CE-marking is in accordance with MDR 2017/745
- UDI-DI as provided to the UDI database
- and if applicable, for certificates of conformity, state the unique number of the certificate
2. The Commission may, by means of implementing acts, establish a model for certificates of free sale, taking into account international practice as regards the use of certificates of free sale. Those implementing acts shall be adopted in accordance with the advisory procedure referred to in Article 114(2).
It might be that the commission publishes an implementation act on a model on how to establish certificates of free sale.
