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Is anyone familiar with Article 60 Certificate of Free Sale

Ed Panek

QA RA Small Med Dev Company
Staff member
Super Moderator
#1
Is anyone familiar with this? Is this a document we include with each shipment?

Article 60 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. 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)
 
Elsmar Forum Sponsor
#2
That certificate is an evidence that the medical devices are legally sold or distributed in the open market, being certified/registered with the regulatory authorities in the country of origin. So, if you intend to enter into the market of a 3rd part country to the EU, the certificate of free sale may be required for device certification/registration.
 

Cybel

Involved In Discussions
#3
You don't have to include the free sale certificate with each shipment. FSC may be required by some countries outside EU to European manufacturer/ authorised representatives in case they need to proceed with initial registration (or renewal) in that country.
 
#5
Jumping on this thread, if a UK based manufacturer has an FSC from MHRA (country of registration), is it now necessary (under MDR) to apply for an FSC from the country in which the Authorised Representative is based? Thanks
 

koulidis

Starting to get Involved
#6
Jumping on this thread, if a UK based manufacturer has an FSC from MHRA (country of registration), is it now necessary (under MDR) to apply for an FSC from the country in which the Authorised Representative is based? Thanks
Good question. The FSC is issued for exporting to countries outside EU. The manufacturer is always responsible for issuing the FSC. If MHRA can issue a FSC i don't see a reason for having the ECREP issuing one as well.
 

Billy Milly

Starting to get Involved
#7
FSC is issued by CAs, not manufacturers...
Green2021, you are correct. If you need a FSC (stating that product is registered somewhere within EU), CA in the country of your AR is the right address.
 
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