"Placing on the market" and "putting into service" are two different legal events in the MDR, defined in Articles 2(28) and 2(31), and they are not synonyms. Placing on the market happens the first time a specific device is made available in the EU. Putting into service happens the first time that device is supplied to the end user ready for use. The transitional provisions in Article 120 — including the extended dates under Regulation (EU) 2023/607 — hang off these definitions, and misreading them costs founders certificates.

By Tibor Zechmeister and Felix Lenhard.

TL;DR

  • Article 2(28) defines "placing on the market" as the first making available of a device, other than an investigational device, on the Union market.
  • Article 2(29) defines "making available on the market" as any supply of a device for distribution, consumption or use on the Union market in the course of a commercial activity.
  • Article 2(31) defines "putting into service" as 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.
  • Article 5(1) prohibits placing on the market or putting into service unless the device complies with MDR — both events, not just one, are gated.
  • Article 120 transitional provisions use "placed on the market" as the hinge for legacy MDD certificates, which is why the difference between the two definitions matters for deadline planning.

Why this distinction trips founders up

Ask a first-time founder when their device has "entered the market" and you will hear answers ranging from "when the factory shipped the first unit" to "when the first hospital actually used it on a patient". The MDR treats those as two different events, and it cares about both. Getting the vocabulary right is not academic — it determines which version of the regulation applies to a given device, whether a legacy certificate still protects it, and when the clock on transitional provisions started or stopped.

I have sat in Notified Body audits where the entire discussion about whether a device was legacy MDD or had to be re-certified under MDR came down to a single question: was this specific unit placed on the market before 26 May 2021, or only afterwards? The answer turned on Article 2(28). Founders who had not internalised the definition argued the wrong point for an hour and lost.

What MDR actually says

Article 2(28) defines placing on the market as: "the first making available of a device, other than an investigational device, on the Union market". Three things are load-bearing here. First, it is the first making available — not every subsequent sale. Second, it is a device — meaning each individual unit, each physical item identified by its serial number or lot, placing itself on the market the first time it leaves the manufacturer's control into the distribution chain. Third, investigational devices are excluded.

Article 2(29) defines making available on the market as: "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". Making available is the broader concept. Every sale, transfer, donation, or loan of a device in commercial activity is a making available. The first making available of a given unit is the placing on the market.

Article 2(31) defines putting into service as: "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". The final user is the person or institution that will actually use the device on a patient. Putting into service is about readiness for use, not about the economic transfer.

Article 5(1) is the operative prohibition: "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." Both verbs appear. You cannot place on the market a non-compliant device, and you cannot put into service a non-compliant device. Each verb opens its own door into the MDR obligation stack.

Article 120 — the transitional provisions, as amended by Regulation (EU) 2023/607 — uses "placed on the market" as the pivot. Devices lawfully placed on the market before specified dates, and meeting the conditions set in Article 120, can continue to be made available and put into service beyond those dates. The wording matters: it is "placed on the market" that freezes the legal status of a unit, not "put into service".

A worked example: one Class IIb device, two dates

Consider a Class IIb surgical instrument. A hospital orders 50 units from the manufacturer on 10 April 2021. The manufacturer ships them on 20 April 2021. The hospital receives and places them in its central sterile supply department. The first time one of those units is used in a surgical procedure is 14 July 2022.

When was each unit placed on the market? Under Article 2(28), when it was first made available in the course of commercial activity. That is the manufacturer's supply to the hospital in April 2021 — before 26 May 2021. So under Article 120, these units were placed on the market under the previous MDD regime and are legacy devices eligible for the transitional provisions, provided all the Article 120 conditions are satisfied.

When were they put into service? Under Article 2(31), when made available to the final user as ready for use. For the unit used on 14 July 2022, putting into service happened in 2022. That is after MDR date of application. But because placing on the market occurred before, Article 120 allows putting into service to continue under the transitional regime.

Now flip the example. Same device, same hospital, but the manufacturer ships 50 new units on 1 September 2022. Those units were placed on the market for the first time in September 2022 — after 26 May 2021. Article 120 does not help. They must be fully MDR compliant at the moment of placing on the market. The fact that they look identical to the April 2021 units is irrelevant. Each unit has its own placing-on-the-market moment, and that moment fixes the regime.

Founders who think "the product is legacy" tend to lose this argument. The Regulation talks about devices, meaning units, not product families.

The Subtract to Ship playbook

1. Write the definitions on a sticky note above your desk. Article 2(28), 2(29), 2(31). Read them verbatim, not paraphrased. Founders who cannot recite the difference will eventually misuse the terms in technical documentation or in an audit.

2. Build traceability for the placing-on-the-market event of each unit. Your QMS records should allow you to identify, for any serial number or lot, the date it first left your control into the distribution chain. That is the event that fixes the regulatory regime for that unit. Without that record you cannot defend a legacy claim.

3. Do not conflate shipping with putting into service. Shipping to a distributor is making available. Shipping to a hospital's central stores is making available. Putting into service happens when the final user is handed the device ready for use. Your commercial contracts and your clinical support documentation should reflect the difference, because the obligations for installation, training, and initial support often tie to putting into service.

4. Plan transitional provisions around the earlier date. If you are managing a legacy portfolio under Article 120, your cut-off planning must use the placing-on-the-market dates, not the put-into-service dates. Every unit that was placed on the market after the cut-off is a new MDR obligation, even if it sits on a shelf unused for years.

5. Check Article 120 against the current consolidated text. The amendments from Regulation (EU) 2023/607 shifted several dates. Do not rely on the 2017 original. The current consolidated version of the MDR is the only reliable reference.

6. Investigational devices are outside both definitions. Article 2(28) and 2(31) explicitly exclude them. If you are in a clinical investigation under Chapter VI, the definitions do not apply and the investigational device regime governs instead.

Reality Check

  1. Can you state the exact wording of Article 2(28) without paraphrasing?
  2. For any given unit in your production history, can you produce the date it was first made available on the EU market?
  3. Do your QMS records distinguish between shipping to distributors and putting into service at end users?
  4. Have you verified which Article 120 transitional dates apply to your device class under the consolidated text including (EU) 2023/607?
  5. If you hold legacy MDD certificates, have you identified which units were placed on the market before the relevant cut-off?
  6. Do your sales contracts clarify who puts the device into service and when?
  7. If an auditor asked "when was this unit placed on the market", could you answer with a document reference?

Frequently Asked Questions

Is placing on the market the same as the first sale? Not exactly. It is the first making available of a device in the course of commercial activity on the Union market, which can include free transfers. For most manufacturers, the first sale is the placing on the market, but donations, samples, or transfers inside the supply chain can also count under Article 2(29).

Does putting into service require installation? It requires the device to be made available to the final user as ready for use for its intended purpose. For a device that needs installation, putting into service typically happens after installation is complete. For a consumable, putting into service can coincide with delivery.

Why does the difference matter for Article 120? Because Article 120 uses "placed on the market" as the pivot for whether the legacy regime applies. A unit placed on the market before the relevant cut-off and meeting the Article 120 conditions can continue to be made available and put into service under transitional rules. A unit placed on the market after the cut-off cannot.

Are investigational devices placed on the market? No. Articles 2(28) and 2(31) explicitly exclude investigational devices from both definitions. Investigational devices are governed by Chapter VI on clinical investigations.

If I give a prototype to a doctor for free, is that placing on the market? If it is a CE-marked device and the transfer is part of commercial activity (including promotional use), yes, under Article 2(29) it can be a making available, and the first such act is placing on the market. If it is an investigational device under a clinical investigation, no.

Does every unit have its own placing-on-the-market date? Yes. The definition refers to a device, meaning the individual unit. Your traceability records should be able to identify, unit by unit, when it was first made available on the EU market.

Sources

  1. Regulation (EU) 2017/745 on medical devices, consolidated text. Articles 2(28), 2(29), 2(31), 5, 120.
  2. Regulation (EU) 2023/607 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards transitional provisions.