Placing on the Market, Making Available and Putting Into Service: The Three Definitions That Decide Which Rules Apply

Three defined terms in Article 2 of MDR 2017/745 carry most of the regulation's timing. Making available, placing on the market and putting into service look like three ways of saying the same thing. They are not. Each one triggers a different set of duties, and almost every transitional deadline, registration requirement and economic operator obligation is anchored to one of them.

Getting them wrong is expensive in a specific way: it produces confident answers to the wrong question. A manufacturer that believes its devices were "placed on the market" when they entered a European warehouse will reach one conclusion about a certificate deadline; the same manufacturer reading Article 2(28) properly will reach another. This guide sets out the three definitions from the text and the obligations that attach to each.

Making available: the wide term

The widest of the three is defined as follows: "'making available on the market' means any supply of a device, other than an investigational device, for distribution, consumption or use on the Union market in the course of a commercial activity, whether in return for payment or free of charge" (MDR Article 2(27)).

Four elements matter. There must be a supply, which means a transfer to another party rather than internal movement. The supply must be for distribution, consumption or use, which excludes goods merely in transit. It must be on the Union market. And it must occur in the course of a commercial activity — but payment is irrelevant, so free samples, demonstration units and devices supplied for evaluation are all making available.

Making available is the term used where the regulation wants to capture every step in the chain. It is why distributor obligations attach to distributors who never import anything, and why the labelling language rules bite in each Member State where a device reaches a user.

Placing on the market: the moment that happens once

The narrow term is defined by reference to the wide one: "'placing on the market' means the first making available of a device, other than an investigational device, on the Union market" (MDR Article 2(28)).

The word doing the work is first. Placing on the market is not a status a company holds; it is an event that occurs once for each individual device. When a manufacturer outside the Union sells a consignment to a European importer, those units are placed on the market at that supply. When the importer sells them on to a hospital, that is a further making available, not a second placing.

Two practical consequences follow. First, stock sitting in a European warehouse that has not been supplied to anybody has not been placed on the market. It has been shipped, cleared and stored, none of which is a supply for distribution, consumption or use. Second, the analysis is per unit rather than per model, which is what makes the transitional provisions workable: a device lawfully placed on the market under one legal position keeps that status even after the rules change for units that follow.

Article 5(1) then ties compliance to that moment: "A device may be placed on the market or put into service only if it complies with this Regulation when duly supplied and properly installed, maintained and used in accordance with its intended purpose." (MDR Article 5(1)) Everything that has to be true of a device — the CE marking, the declaration of conformity, the technical documentation, the UDI assignment, the registration — has to be true by then, not shortly afterwards.

Putting into service: the end of the chain

The third term captures arrival at the user: "'putting into service' means the stage at which a device, other than an investigational device, has been made available to the final user as being ready for use on the Union market for the first time for its intended purpose" (MDR Article 2(29)).

Putting into service matters for devices that are installed rather than sold across a counter — imaging systems, sterilisers, fixed equipment — where the gap between supply and readiness for use can be months. It also has a special rule for hospitals that make their own devices: "Devices that are manufactured and used within health institutions shall be considered as having been put into service." (MDR Article 5(4)) That deeming provision is what brings in-house devices inside the regulation at all, before the Article 5(5) exemption is considered.

Which obligation attaches to which moment

Reading the operative provisions against the three definitions gives a usable map.

Obligation	Anchored to	Source
Device must comply with the Regulation	Placing on the market or putting into service	Article 5(1)
CE marking affixed	Before placing on the market	Article 20(4)
Sole authorised representative designated	Before placing on the market	Article 11(1)
UDI assigned to the device and packaging	Before placing on the market	Article 27(3)
Importer verifications carried out	In order to place on the market	Article 13(2)
Distributor verifications carried out	Before making available	Article 14(2)
Information in the required language	Where made available to the user	Article 10(11)

The pattern is consistent. Duties that go to the identity and conformity of the device attach to placing on the market. Duties that go to the local presentation of the device — language, local contact details, national registration — attach to making available in a particular Member State.

Why the authorised representative appointment is a placing question

Article 11(1) is drafted in the form of a prohibition: "Where the manufacturer of a device is not established in a Member State, the device may only be placed on the Union market if the manufacturer designates a sole authorised representative." (MDR Article 11(1)) The mandate is a precondition of the first supply, and Article 11(2) requires it to be accepted in writing to be valid.

This is more than a formality. If a consignment reaches a European customer before the mandate is signed, those units were placed on the market in breach of Article 11(1), and the breach cannot be cured retrospectively by appointing a representative afterwards. The device also cannot be registered correctly, because the representative's EUDAMED single registration number is part of the device registration under Article 31 — see EUDAMED SRN registration.

Manufacturers planning a first shipment should therefore work backwards from the intended supply date: mandate signed, registration complete, labelling carrying the representative's details under Section 23.2 of Annex I, and only then the shipment. The practical consequences of getting the sequence wrong are set out in what happens without an EU authorised representative.

Distance selling and the definition that catches sellers without a warehouse

Online sales sit awkwardly against the traditional supply chain, so Article 6 addresses them directly: "A device offered by means of information society services, as defined in point (b) of Article 1(1) of Directive (EU) 2015/1535, to a natural or legal person established in the Union shall comply with this Regulation." (MDR Article 6(1)) The trigger is the offer to a person established in the Union, not the location of the seller or the stock. Our full treatment is in distance selling of medical devices in the EU.

Getting the vocabulary right in your own documents

Three habits prevent most of the confusion. Write placed on the market only where you mean the first commercial supply of specific units, and record the date and the consignment. Write made available where you mean any onward supply, including free of charge. Reserve put into service for the moment a final user has the device ready for its intended purpose.

Competent authorities read these words as defined terms. So do notified bodies, and so does any authorised representative reviewing a file before signing a mandate. Using them precisely in your declaration of conformity, your distribution agreements and your post-market records removes an entire category of avoidable argument.

Medex Kurumsal Danismanlik acts as EU authorised representative under MDR and IVDR for manufacturers established outside the Union, with EUDAMED registration TR-AR-000057550. If a first European shipment is being planned, the mandate has to be in place before it leaves. Details of the appointment are on our EU authorised representative page.

Medex Kurumsal as your EU authorised representative

If you place medical devices or in vitro diagnostics on the European market from outside the Union, Article 11 of MDR 2017/745 — and Article 11 of IVDR 2017/746 for in vitro diagnostics — requires a single authorised representative established in a Member State before those devices reach the market. Medex Kurumsal Danismanlik acts as EU authorised representative under both Regulations, registered in EUDAMED under SRN TR-AR-000057550.

What the mandate covers: verification of the EU declaration of conformity and the technical documentation before signature rather than after; the Article 11(3)(a) copy of the file kept available for the full retention period; EUDAMED actor and device registration and the Basic UDI-DI submission; the registered EU address printed on your label and instructions for use; handling of competent authority requests, samples and information in the language of the Member State concerned; and the vigilance interface under Articles 87 to 90.

We review the file before accepting a mandate, because Article 11(5) makes the authorised representative jointly and severally liable for defective devices where the manufacturer has not complied with Article 10. A file we have not read is a liability we cannot price. Our fee structure is published on the EU authorised representative cost page, and the scope of the service is set out under EU authorised representative. Send us the declaration of conformity and the device list and we will tell you within two working days whether the file is ready for a mandate and what is missing if it is not.