Free Sale Certificate for Medical Devices: What MDR Article 60 Requires
Updated: Aug 15
A free sale certificate is the document a non-EU regulator most often asks for and the one EU law says least about. Article 60 of Regulation (EU) 2017/745 runs to two paragraphs. Article 55 of Regulation (EU) 2017/746 is its in vitro diagnostic twin, differing only in cross-references. Between them they settle four questions and leave everything else to twenty-seven national administrations.
What Article 60 actually says about the free sale certificate
Article 60(1) provides that 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. Note the verb: shall issue. This is an obligation on the Member State, not a discretion.
The same paragraph fixes the content. The certificate shall set out the Basic UDI-DI of the device as provided to the UDI database under Article 29, and where a notified body has issued a certificate pursuant to Article 56, the certificate of free sale shall set out the unique number identifying that certificate as referred to in Section 3 of Chapter II of Annex XII. Those are the four mandatory elements: the establishment declaration, the may-be-marketed declaration, the Basic UDI-DI, and the notified body certificate number where one exists.
Article 60(2) allows the Commission to establish a model for certificates of free sale by implementing act, taking into account international practice, under the advisory procedure in Article 114(2). No such implementing act has been adopted. That single absence explains most of what follows in this article: without a Union model, every competent authority issues its own form, on its own terms, with its own validity period, its own batching limits and its own fee. Article 55(2) IVDR contains the same enabling provision and the same gap.
Who may request one, and which Member State must issue it
Only a manufacturer or an authorised representative may request an Article 60 certificate. The network of national competent authorities set this out in its Questions and Answers on Certificates of Free Sale and Article 60, endorsed at the 50th CAMD meeting in Paris in June 2022: only manufacturers or authorised representatives with a registered office in the jurisdiction may apply. Distributors and importers cannot. Nor can producers of systems or procedure packs under Article 22, because they are not manufacturers of the devices concerned. Several national authorities state the same in their own guidance — the Belgian FAMHP records that distributors lost this route under the Regulations.
The Member State that must issue is the one in which the requester has its registered place of business. For a manufacturer established outside the Union the consequence follows directly from the text: the manufacturer has no registered place of business in any Member State, so the only Member State bound by Article 60(1) is the one where its authorised representative is established. Your representative’s jurisdiction is where your export documentation comes from, and it is worth knowing that before you choose one rather than after.
One thing this does not create is a hierarchy. The Commission’s Factsheet for authorities in non-EU/EEA states, version of 18 December 2024, records that competent authorities of all EU Member States may issue certificates of free sale, which all have the same value. Shopping for a certificate from a more recognisable Member State achieves nothing; requesting one from a Member State where you are not established simply fails.
What a free sale certificate is not
It is not a conformity assessment document. Article 60 sits outside the machinery of CE marking, the EU declaration of conformity and notified body certification; it references those instruments rather than substituting for them. The Danish Medicines Agency states the point without qualification: a certificate of free sale issued by that agency is not to be taken as an approval of the products included on it. Conformity is evidenced by the CE marking, the EU declaration of conformity and the notified body certificate, and third-country authorities can verify notified body scope in NANDO and device and certificate data in EUDAMED.
It is not required to place a device on the Union market. Article 60(1) issues it for the purpose of export and only upon request. The Belgian FAMHP describes it as generally intended for the export of medical devices outside the European Union; the Danish agency restricts it to exports to countries outside the EEA or without mutual recognition agreements with the EU; the Finnish Fimea names the export destination country on the certificate itself. A manufacturer selling only within the Union never needs one.
It is worth noting that national authorities describe it in different registers. The Irish HPRA calls it a document used in the registration of a device in a third country which indicates that a device is compliant with EU law — a looser formulation than the Danish one. Both are official statements from competent authorities, and the gap between them is exactly the space in which third-country reviewers over-read the certificate. When a destination regulator treats a free sale certificate as an approval, the answer is to supply the declaration of conformity and the notified body certificate alongside it, not to argue about the wording.
Validity, fees and legalisation: everything the Regulation does not say
There is no legally fixed validity period. The CAMD Q&A states plainly that the Regulation does not prescribe a specific expiry time for a certificate of free sale, and recommends that authorities align expiry with the underlying declarations of conformity and notified body certificates. What that produces in practice is divergence. Denmark issues for a maximum of two years, or shorter where the notified body certificates require it. Austria issues for a maximum of two years and caps validity for legacy devices at the relevant transitional deadline. Ireland issues certificates bearing an issue date but no expiry date, with a wet signature and stamp.
Batching and content rules are equally national. Belgium limits a single application to ten medical or active implantable devices, or forty in vitro diagnostics, of the same class and under the same CE certificate, and quotes roughly five weeks’ processing. Finland prohibits combining Regulation and Directive devices, or multiple trade names or single registration numbers, on one certificate. Denmark requires exact product names and Basic UDI numbers matching the declarations of conformity, and caps applications at fifty declarations. Fees exist everywhere and are set nationally.
Legalisation is where schedules break. Austria’s BASG states expressly that applicants must obtain the additional certification from the Federal Ministry for European and International Affairs themselves, at the Office for Consular Legalisations. The CAMD Q&A notes that Member States may use electronic signatures but that some third countries do not accept them — a decisive point where your issuing authority has moved to e-signed certificates and your destination regulator has not. Add five weeks of issuance to an apostille or consular chain and the front half of a third-country submission is measured in months, not days.
Legacy devices, and why Article 60 does not reach them
Article 60(1) is limited to a device “bearing the CE marking in accordance with this Regulation”. A legacy device placed on the market under the Article 120 transitional provisions bears CE marking under Directive 93/42/EEC or Directive 90/385/EEC, not under the MDR. The CAMD Q&A draws the conclusion directly: a certificate of free sale issued in accordance with Article 60 of the MDR can only be issued for MDR-compliant devices, and a certificate for legacy devices continuing to be placed on the market under Article 120(3) can only be issued under the Directives.
This is not a dead end, only a different instrument. National provisions supporting the Directives remain available for devices placed on the market before the MDR applied, for devices affected by MDR up-classification, and for Article 120(3) devices. The Commission’s Factsheet for authorities in non-EU/EEA states records that certificates of free sale based on valid notified body certificates issued under the Directives remain valid after 26 May 2021, or 26 May 2022 for in vitro diagnostics, until the corresponding certificates expire.
Member States implement the split visibly. Ireland issues Directive-era certificates under one legal framework and MDR and IVDR certificates under another, and distinguishes them on the face of the certificate. Austria requires separate applications for MDR devices, IVDR devices and Directive devices. Finland forbids mixing them. If your portfolio spans both regimes — and in 2026 most portfolios do — you are managing two certificate streams, not one, and a destination regulator that receives the wrong one will send it back.
Türkiye: the serbest satış sertifikası alongside the EU certificate
Türkiye applies MDR-aligned legislation. The Tıbbî Cihaz Yönetmeliği was published in the Resmî Gazete of 2 June 2021, No. 31499 (mükerrer), in force from 26 May 2021, alongside the İn Vitro Tanı Amaçlı Tıbbî Cihaz Yönetmeliği. The Commission’s Notice to Stakeholders on the EU-Türkiye Customs Union Agreement in the field of medical devices, published in March 2022, confirms that Türkiye has aligned its legislation with Regulation (EU) 2017/745 and Regulation (EU) 2017/746, that a manufacturer established outside the Customs Union needs to designate only one authorised representative in either the EU or Türkiye, and that certificates issued by Turkish notified bodies allow devices to circulate freely in the EU.
TİTCK issues the Turkish equivalent, the serbest satış sertifikası. Its published announcement on free sale certificate applications makes registration and approval of the manufacturer and its products in the national product database a precondition, and sets out the application documents and a tiered fee by number of products. That announcement predates both ÜTS and the 2021 regulations, so the current procedure should be confirmed with TİTCK before an application rather than assumed from it — but the underlying logic, that the certificate follows the registration, has not changed.
One open question is worth naming rather than answered too confidently. Neither the Commission Notice, nor MDCG 2022-16, nor the CAMD Q&A addresses what happens to Article 60 where a non-EU manufacturer’s sole authorised representative is established in Türkiye rather than in a Member State. On the face of Article 60(1), no Member State would then have the requester’s registered place of business on its territory, and the corresponding certificate would come from TİTCK. That is a reading of the text, not published guidance, and a manufacturer whose export dossiers depend on an EU-issued certificate should factor it into where the mandate sits. We are not a law firm and do not provide legal advice.
Sources
Regulation (EU) 2017/745, Article 60 and Annex XII, Chapter II, Section 3; Regulation (EU) 2017/746, Article 55
CAMD — Questions and Answers on Certificates of Free Sale and Article 60 of Regulation (EU) 2017/745 on medical devices, endorsed at the 50th CAMD meeting, Paris, June 2022
European Commission — Factsheet for authorities in non-EU/EEA states on medical devices and in vitro diagnostic medical devices, version of 18 December 2024
European Commission (DG SANTE and DG NEAR) — Notice to Stakeholders: EU-Turkey Customs Union Agreement in the field of medical devices, March 2022; MDCG 2022-16 — Guidance on Authorised Representatives, October 2022
Tıbbî Cihaz Yönetmeliği, Resmî Gazete, 2 June 2021, No. 31499 (mükerrer); TİTCK — announcement on free sale certificate applications by medical device manufacturers
National competent authority guidance on certificates of free sale: Danish Medicines Agency, BASG (Austria), HPRA (Ireland), FAMHP (Belgium), Fimea (Finland)
Who wrote this
Medex is a medical device manufacturer established in Ankara and a registered authorised representative in EUDAMED under SRN TR-AR-000057550. We are not a law firm and do not provide legal advice. Send us your device list and the destination markets you are registering in, and we will respond in writing.
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