Exporting a CE-marked medical device outside the EU typically requires a Free Sale Certificate issued under MDR Article 60 by the competent authority of the manufacturer's member state. Customs clearance additionally depends on correct HS codes, accurate commercial invoices, and in some cases dual-use export controls.

By Tibor Zechmeister and Felix Lenhard.

TL;DR

  • MDR Article 60 governs the issuance of Free Sale Certificates for EU-manufactured medical devices intended for export outside the Union.
  • Free Sale Certificates are issued by the competent authority of the member state where the manufacturer or authorised representative is established, not by a central EU body.
  • Validity periods vary by member state and importing country, typically 6 to 24 months, and some importing countries require legalisation or apostille.
  • Customs clearance depends on correct HS/CN codes. These are set by the importing country and can vary even for the same device.
  • Dual-use considerations apply to some medical devices, particularly certain imaging, laser, and diagnostic technologies with potential non-medical applications.
  • The most common shipment failures are missing or expired Free Sale Certificates, mismatched HS codes between invoice and customs declaration, and incomplete importer registration in the destination market.

Why this matters

The first international shipment is a rite of passage for a MedTech startup. A Polish hospital orders three devices. A Brazilian distributor commits to a pilot. A hospital in Dubai is ready to integrate. And then the shipment sits in customs for three weeks because someone forgot about a Free Sale Certificate, or the HS code on the commercial invoice does not match what the destination customs authority expects.

I have seen this pattern repeat across dozens of startups. The CE mark is in place, the QMS is certified, the device works. What fails is the boring paperwork that sits between your warehouse and your customer. Customs officials are not regulators in the MDR sense. They enforce customs law, trade controls, and import documentation rules. A perfectly legal, perfectly CE-marked device gets held up because the export paperwork was wrong.

This post covers the two documents that founders underestimate most: the Free Sale Certificate and the customs classification code. Get these right and most shipment failures disappear.

What MDR actually says

MDR Article 5 ("Placing on the market and putting into service") governs the conditions under which a medical device may be placed on the EU market. Once a device has a valid CE mark and meets Article 5 requirements, it can circulate within the EU single market. Export outside the EU is not governed by Article 5 itself, but by the export rules of the destination country combined with EU customs law.

MDR Article 60 ("Certificates of free sale") is the relevant provision for exports. It establishes that, for the purpose of export, member states shall, upon request from a manufacturer or authorised representative, issue a certificate of free sale stating that the manufacturer or authorised representative has a place of business in their territory and that the device bearing the CE mark in accordance with the regulation may be marketed in the Union. The certificate is valid for the period indicated on the certificate, not exceeding five years, and not more than the expiry date of the certificate referred to in Article 56, where applicable.

Key implications:

  • The Free Sale Certificate is not issued by the European Commission. It is issued by the competent authority of the member state where the manufacturer (or authorised representative for non-EU manufacturers) has a place of business.
  • Different member states have different application processes, different fees, and different processing times. In Germany, BfArM issues them. In France, ANSM. In Austria, BASG. In Italy, the Ministero della Salute.
  • The certificate states a fact: this manufacturer can legally place this device on the EU market. It is not an export licence, not an endorsement, and not a guarantee of acceptance by the importing country.
  • Validity is capped at five years under Article 60, but many competent authorities issue for shorter periods, and many importing countries require certificates dated within the last 6 to 12 months.

Beyond Article 60, the device must comply with EU customs procedures. Goods leaving the EU require an export declaration, a commercial invoice with accurate descriptions and values, the correct Combined Nomenclature (CN) code, and. For some devices. A dual-use licence under Regulation (EU) 2021/821.

A worked example

A Class IIa active diagnostic device from an Austrian startup is shipping to a distributor in Saudi Arabia. The Saudi FDA (SFDA) requires, as part of its device registration dossier:

  • A valid CE certificate from the notified body.
  • A Free Sale Certificate issued by the Austrian competent authority (BASG), legalised by the Austrian Ministry of Foreign Affairs and then by the Saudi embassy in Vienna.
  • A commercial invoice in English with the correct HS code.
  • A certificate of origin.

The founder applied to BASG for the Free Sale Certificate. Processing took four weeks. The fee was modest. The document arrived. Then came the legalisation chain: Austrian Foreign Ministry for apostille, then Saudi embassy legalisation, which took another three weeks and a courier round trip. Total elapsed time from SFDA requirement to shipment-ready documentation: approximately nine weeks.

On the customs side, the device was initially declared under an HS code appropriate for "medical instruments and appliances," but the Saudi customs authority reclassified it under a slightly different code that attracted a higher import duty. The distributor absorbed the difference once, then demanded corrected documentation for all future shipments.

The lesson: every importing country has its own interpretation of HS codes, and the codes used on the EU export declaration are not always identical to the codes the importing country applies on arrival. Align with the distributor and the destination customs broker before the first shipment, not after.

The Subtract to Ship playbook

Step 1: Map your documentation stack per destination before shipping. For every country you plan to ship to, list: (a) whether a Free Sale Certificate is required, (b) whether legalisation or apostille is required, (c) the typical processing time for each step, (d) the HS/CN code the destination expects, (e) whether dual-use controls apply, and (f) any country-specific import registration. Do this once, update quarterly.

Step 2: Treat the Free Sale Certificate application as a standing process, not a one-off. If you ship internationally regularly, apply for new certificates on a rolling basis so you always have a current one ready. Many competent authorities allow you to request multiple certified copies at a small incremental cost.

Step 3: Verify HS codes with a customs broker in the destination country. EU CN codes and destination HS codes are not always identical. A 30-minute call with a destination-country customs broker before the first shipment can save weeks of delay. Document the agreed code in your shipping SOP.

Step 4: Build a commercial invoice template with everything customs actually reads. Accurate device description (matching the CE certificate exactly), quantity, unit value, total value, HS code, country of origin, Incoterms, purchaser details, intended end use, and a clear statement that the goods are CE-marked medical devices. Most shipment delays are avoidable with a properly structured invoice.

Step 5: Check dual-use early. Some medical devices. Particularly high-energy lasers, certain imaging technologies, ultrasound phased arrays, and software with cryptographic or AI components. Fall within the scope of EU Regulation (EU) 2021/821 on dual-use exports. If any of this is in your architecture, check before you ship. Retrofitting a dual-use licence after shipment has started is painful.

Step 6: Build an "importer of record" checklist. In most destination countries, someone has to be legally responsible for the import. Sometimes that is your distributor, sometimes a specialised importer, sometimes your local subsidiary. Clarify this in writing before shipping. "We thought the distributor was importer of record" is one of the most expensive sentences in international MedTech.

Reality Check

  1. For every country on your shipment list, do you know whether a Free Sale Certificate is required, and if so, from which authority?
  2. Do you know the processing time for a Free Sale Certificate from your member state's competent authority?
  3. Have you verified the HS/CN code for your device with a customs broker in each destination country?
  4. Does your commercial invoice template include device description, HS code, Incoterms, country of origin, and end-use statement?
  5. Have you assessed whether any component of your device triggers dual-use export controls?
  6. Is there written agreement with every distributor specifying who acts as importer of record?
  7. Do you maintain a rolling stock of valid Free Sale Certificates to avoid last-minute application delays?
  8. Have you documented the legalisation chain (apostille, embassy) for every destination that requires it?

Frequently Asked Questions

Who issues Free Sale Certificates for EU-manufactured devices? The competent authority of the member state where the manufacturer or EU authorised representative has a place of business. In Austria this is BASG, in Germany BfArM, in France ANSM, in Italy the Ministero della Salute, and so on. The European Commission does not issue these certificates.

How long is a Free Sale Certificate valid? MDR Article 60 caps validity at five years. In practice many competent authorities issue certificates for shorter periods, and many importing countries require the certificate to be dated within the last 6 to 12 months. Always check the destination country's specific requirements.

Is a Free Sale Certificate required for exports to Switzerland or the UK? Switzerland requires CH-REP registration and often accepts CE documentation directly. The UK requires UKRP registration and MHRA registration but has its own process. Free Sale Certificates are more common for exports to the Middle East, Latin America, and parts of Asia.

What is the difference between an HS code and a CN code? The Harmonized System (HS) is the international 6-digit classification administered by the World Customs Organization. The EU Combined Nomenclature (CN) extends the HS with additional digits for EU-specific purposes. Destination countries may use their own further extensions on top of the HS base.

Can a customs broker reclassify our device after export? Yes. Destination customs authorities have the final say on classification at the point of import. A broker can propose a code, but the customs authority can challenge it and apply a different one, sometimes with different duty implications.

What happens if we ship without the correct paperwork? In the best case, the shipment is delayed and documentation is corrected. In worse cases, the shipment is returned at your cost or seized. In the worst case, repeated non-compliance can affect your standing as an exporter with that destination.

Sources

  1. Regulation (EU) 2017/745 on medical devices, consolidated text. Articles 5, 56, 60.
  2. Regulation (EU) 2021/821. EU dual-use export control regime.
  3. Commission Implementing Regulation (EU) 2021/2078. Eudamed rules.
  4. World Customs Organization. Harmonized System Nomenclature.