Certificate of free sale, export certificate, certificate of marketability, free trade certificate, free sale certificate, free sales certificate. Even the authorities can’t agree on the name. However, these “certificates of free sale” are essential for manufacturers that export
This article will explain when you need a certificate of free sale, how and where you can obtain one, and the requirements you have to meet to do so.
If a manufacturer wants to place their product (e.g., a medical device) on the market in Europe, they have to comply with specific rules. For example, they must carry out a conformity assessment procedure to demonstrate that their device complies with the essential requirements set out in the EU regulations. In the case of medical devices, these regulations are the Medical Device Directive (MDD) and the MDR. The USA also has very clear requirements for placing devices on the market. Certificates of free sale are not needed in these cases.
A lot of other countries, for example Pakistan and Colombia, allow medical devices authorized for other markets, e.g., the European market, to be placed on the market. To take advantage of this option, manufacturers have to be able to provide evidence that their devices can actually be legally marketed there.
This evidence takes the form of a confirmation from the competent authority. In Germany, for example, this competent authority would be the regional councils or state offices. Depending on the authority, the confirmations are called certificates of free sale (CFS), export certificates, certificates of marketability or free sale certificates.
Section 34 MPG on the export of medical devices established that authorities had to issue these certificates of free sale (CFS) (free sale certificates, certificates of marketability). It said:
“Upon application by the manufacturer or his/her authorized representative, the competent authority shall issue a certificate stating that the medical device in question is marketable in Germany.”
In the same section, the MPG stated:
“Medical devices which are subject to a prohibition as referred to in Section 4(1) may only be exported if the competent authority of the country of destination has authorized the import after having been informed by the competent authority regarding the reasons for the prohibition.”
Section 4(1) refers to products for which
“there are grounds to suspect that the safety and health of patients, users or third persons could be compromised, directly or indirectly, to a degree which exceeds tolerable limits according to medical scientific knowledge when properly operated, maintained and used in accordance with their intended purpose, or the date up until which safe use could be proven has elapsed.”
In other words, the MPG prohibited manufacturers from exporting non-conforming devices unless the destination country explicitly agreed to their import.
The EU regulations the MDR and IVDR regulate certificates of free sale in Article 60 and Article 55, respectively. Both articles are almost identical to the letter and establish that:
The two regulations give themselves the right to establish implementing acts for this issue, but no such act has been published to date.
Use the FAQs from the CAMD (Competent Authorities for Medical Devices).
It answers, for example, the questions of whether authorities can issue certificates of free sale to marketers of systems and procedure packs and which options are open to distributors and importers. It also describes how legacy products are handled.
National laws implement the requirements of the MDR and IVDR. In the case of Germany, this is done in Section 10 of the MPDG. This paragraph also applies to devices that are still being placed on the market under the old EU directives. It states that the “competent” authorities are responsible for issuing the certificates of free sale. Depending on the federal state, these are (still) the regional councils, trade supervisory offices, governments or state offices.
In May 2022, sentence 1 of Section 10 was amended and further adapted to the MDR and IVDR. It now explicitly states who the eligible applicants according to the EU regulations are, namely manufacturers, authorized representatives, producers of systems and procedure packs, and importers.
Manufacturers can request certificates of free sale from their competent authority, i.e., the aforementioned regional councils, governments, state offices and trade supervisory offices.
Companies that have their registered head office outside the EU but are represented by an EU representative in Germany can also request an “export certificate” through the EU-representative.
You can find examples of the requirements governing free sales certificates here:
As a rule, manufacturers can request certificates of free sale informally, e.g., by email.
The authority needs the following information from the manufacturer to be able to issue the certificate of free sale:
Our own experience of requesting certificates of free sale has been consistently positive. The authorities usually issue them within two weeks. The cost is often less than EUR 100 for an individual device. There are significant discounts for long product lists.