Placing on the market: Definition and regulatory requirements

The EU regulations place high requirements on the so-called placing on the market of medical devices.

Find out in this article what these regulations mean by placing on the market, what misunderstandings and contradictions you must be aware of, and what requirements manufacturers and devices must meet.

1. Placing on the market: Basics

a) Definition of terms / confusion of terms

Medical Device Regulation (MDR)

The Medical Device Regulation defines the term as:

Interpretation of the EU Commission

In the EU Blue Guide, the European Commission discusses the term “placing on the market.”

“A product is placed on the market when it is made available for the first time on the Union market. According to Union harmonisation legislation, each individual product can only be placed once on the Union market.”

EU Blue Guide

The definition is, therefore, similar to the one of the MDR.

The Blue Guide also makes it clear that it concerns the individual device and not a product type:

“As for ‘making available’, the concept of placing on the market refers to each individual product, not to a type of product, and whether it was manufactured as an individual unit or in series.”

EU Blue Guide (highlighted by Johner Institute)

So it really is about the individual product, although this concept is often misunderstood.

Confusion

If you look at the different language versions of the Blue Guide, you can see differences. The German version states: “Placing a product on the market requires an offer or an agreement (written or verbal) between two or more legal or natural persons for the transfer of ownership, possession or other rights concerning the device in question;…”.

In the English version, on the other hand, the statement reads: “Placing a product on the market requires an offer or an agreement (written or verbal) between two or more legal or natural persons for the transfer of ownership, possession or any other property right concerning the product in question;”

The English version, therefore, speaks explicitly of property rights, whereas the German and other language versions only speak of “other rights.” Unfortunately, it is unclear why the Commission has restricted the interpretation in the English version so much. Looking at the individual language versions as a whole and the interpretation of “making available” (also in the English version! see next section), the restriction to property rights only does not appear to be the legislator’s intention.

Differentiation from making available

The MDR defines making available as follows:

The EU Blue Guide takes a similar view and describes “making available” as:

“A product is made available on the market when supplied 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.”

EU Blue Guide

The Blue Guide makes it clear that the term “making available” also refers to each individual device and not to one product type.

Every placing on the market is therefore also a making available (namely the first making available), but not every making available is a placing on the market.

Examples

• An EU distributor who sells a device in the EU that he has obtained from another EU distributor is making it available but not placing it on the market.
• If a non-EU manufacturer transfers its device to a EU distributor (for the first time), this constitutes placing on the market and making available. If this distributor resells the device to a European health institution, this constitutes making available but not placing on the market.

The Blue Guide supplements the topic of making available:

“The making available of a product supposes an offer or an agreement (written or verbal) between two or more legal or natural persons for the transfer of ownership, possession or any other right ( 47) concerning the product in question after the stage of manufacture has taken place. The transfer does not necessarily require the physical handover of the product.”

Blue Guide, Chapter 2.2

Interestingly, in this case the English version also refers to “…other rights” and not “…other property rights”.

Consequences

Class I devices: The distinction between placing on the market and making available was particularly relevant for class I devices that could not benefit from the 2nd Corrigendum (more on this in the article on transition periods). After the cut-off date (May 26, 2021), these devices may only be made available but no longer placed on the market. This means that the device must have already been made available for the first time, which means it is considered to have been placed on the market. This applies to every single device!

Legacy devices: Directive-compliant devices that currently still benefit from the transitional provisions may generally only be placed on the market under the directives until the respective cut-off dates (for more information, see our article on legacy devices). After that, only further making available and putting into service is possible. Therefore, the definitions of both terms are also essential for manufacturers, importers, and distributors of such devices and should be understood accordingly.

Products with a short shelf life: To be made available and put into service after the respective cut-off date (e.g., the validity date of the certificate), devices must have been manufactured and placed on the market before that date. For products with a short shelf life, “production in stock” represents a risk for the distributor, for example, because the devices may no longer be used once the expiration date has passed.

Interim conclusion

The definitions and differentiation of the terms “placing on the market” and “making available” are complex. However, the MDR, and the EU Blue Guide define these terms uniformly and explain them in particular in the Blue Guide.

b) Delimitations

Exclusions

The MDR and IVDR make it clear that placing on the market does not include

1. the supply of medical devices for clinical investigation
2. the supply of in-vitro diagnostics for performance evaluation studies
3. the further making available of a medical device to others after it has been put into service unless it has been refurbished or significantly modified

Borderline cases

For devices produced as a batch, the question arises as to whether the supply of devices from a (new) batch constitutes a first supply, i.e., placing on the market. According to the Blue Guide, the answer is yes. This is because placing on the market refers to “each individual device, regardless of whether it was manufactured as a single unit or in series.”

c) Date of placing on the market

In the EU Blue Guide referenced above, the European Commission assumes that placing on the market occurs as soon as the device is supplied for the first time. This supply usually occurs physically, e.g., by delivery to a distributor with the transfer of certain rights. A device in the manufacturer’s warehouse typically does not constitute placing on the market.

However, physical handover is not a mandatory requirement. Think of software that is offered as a download, for example. Read below to find out when software that is distributed via an app store is considered to be placed on the market.

2. Requirements for placing on the market

a) Medical Device Regulation MDR

The Medical Device Regulation specifies the requirements for placing on the market in various articles (excerpts):

General conformity with the MDR: Article 5 (1) 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. […]

UDI assignment and registration: Article 27 (3) Before placing a device, other than a custom-made device, on the market, the manufacturer shall assign to the device and, if applicable, to all higher levels of packaging, a UDI created in compliance with the rules of the issuing entity designated by the Commission in accordance with paragraph 2.

Before a device, other than a custom-made or investigational device, is placed on the market the manufacturer shall ensure that the information referred to in Part B of Annex VI of the device in question are correctly submitted and transferred to the UDI database referred to in Article 28.

Registration of economic operators: Article 31 (1) Before placing a device, other than a custom-made device, on the market, manufacturers, authorised representatives and importers shall, in order to register, submit to the electronic system referred to in Article 30 the information referred to in Section 1 of Part A of Annex VI […]

Conformity assessment: Article 52 (1) Prior to placing a device on the market, manufacturers shall undertake an assessment of the conformity of that device, in accordance with the applicable conformity assessment procedures set out in Annexes IX to XI.

b) Typical questions

What happens when (harmonized) standards change?

The answer to this question depends, among other things, on the definition of “placing on the market.” The EK-Med has addressed this question and provided answers in document 3.5 A1.

The following, therefore, applies when dealing with amended harmonized standards or in the event of new scientific evidence:

1. the presumption of conformity based on compliance with a superseded harmonized standard (cf. 93/42/EEC Article 5) expires with the expiry of the so-called “doc” (date of cessation of presumption of conformity of the superseded standard). […]

2. the manufacturer can claim the presumption of conformity of the superseded standard until the “doc.”

[…]

5. a lack of reassessment by the manufacturer after the expiry of the “doc” or the lack of knowledge/availability of new harmonized standards or relevant scientific evidence constitute significant non-conformities. […]

EK-Med 3.5 A1

If the above conditions are met, manufacturers may continue to place devices on the market even if a standard has changed. Placing on the market presupposes that the device complies with the (harmonized) standards in force at that time.

Irrespective of this, manufacturers are obliged, as part of the post-production phase or post-market surveillance, to continuously, systematically, and proactively check and ensure, irrespective of changes to the standards, that

1. the device and its benefit-risk ratio correspond to the state-of-the-art,
2. all hazards are identified and, risks are correctly assessed, and
3. all residual risks are acceptable.

Especially because the harmonization process is rather slow, you should consider the following:

When may devices continue to be placed on the market or supplied after May 20, 2021?

Answers to these questions can be found in our article on transition periods.

Is a publication on GitHub a placing on the market?

It has already been claimed that researchers would be taking a risk if they published AI algorithms on GitHub that (could) be used for diagnosis, for example.

In most cases, this assessment is incorrect in several respects. The code is neither a medical device nor is it being placed on the market, especially if the code is not distributed “in the course of a commercial activity”.

3. Typical pitfalls when placing on the market

The Johner Institute regularly observes misunderstandings and traps. You should avoid these at all costs:

a) Accidental placing on the market in beta tests and observational studies

In the case of observational studies and clinical investigations, ensure you do not “accidentally” place the device on the market. The same applies to field tests or beta tests. You must explicitly label the devices as test samples and only make them available to a very small and monitored group of investigators. Manufacturers must comply with numerous regulatory requirements for clinical investigations, which the MDR has further increased.

b) Lack of knowledge about when software is placed on the market

In general, software  on a website or app store must already comply with EU legislation, in this case the MDR, once it is available for download. It does not matter whether someone has already downloaded it or whether money is charged for it. However, the prerequisite is that the offer is aimed at end users in the EU.

Read below to find out when software distributed via an app store is considered to have been placed on the market.

c) Ignorance of the requirements for distance selling

The MDR introduces the concept of distance selling in Article 6. Accordingly, devices for the following services must also meet the requirements of the Regulation:

1. Devices provided through a service
   An example would be an app or website that collects health data from patients and makes diagnostic or therapeutic recommendations on this basis.
   
2. Devices that are not placed on the market but are used to provide diagnostic or therapeutic services
   Examples of this would be devices for telemedical services. A system that doctors use to “remotely” assess patients’ X-ray images would fall into this class. On the other hand, an electronic system used by a doctor in the presence of the patient would not be included because it does not meet the definition in Article 1(1)(b) of Directive (EU) 2015/1535 and is even explicitly excluded in Annex I to the Directive.

Ultimately, these requirements are not new. Even before the MDR came into force, websites and other devices with services provided by electronic means were classified as medical devices if their intended purpose met that of a medical device.

4. Placing on the market of software

For software distributed via app stores, e.g., medical apps, particular questions arise concerning placing on the market. Examples are

1. Who is the person placing on the market? The manufacturer or the app store operator?
2. Is an app download from a non-EU server and a non-EU manufacturer an import into the EU?
3. When does the placing on the market take place?
4. What is the responsibility of the app store operator?
5. Can and must placing on the market be limited to certain countries?
6. Does the MDR change anything? What transitional periods apply?

a) Placing on the market of medical apps

The one placing on the market is the manufacturer. The operator of the app store is a distributor as defined by the MDR:

The operators of the app stores are typically not importers as defined by the MDR:

If a German company places an app in a US store of one of the tech giants, the legal entity operating this US store will not be established in the EU. These companies have usually founded their own companies for the European app stores, e.g., in Ireland or Luxembourg.

c) Point in time of placing on the market

Uploading…

Some notified bodies interpret the uploading of the app to the app store as the moment of placing it on the market, but other notified bodies disagree with this.

… or activating?

They argue that in the app store, the code is again provided with certificates. This would correspond to packaging, which is, therefore to be understood as part of the production process. Only the activation of the app in the app store would thus correspond to placing on the market.

This interpretation means that the manufacturer has an outsourced production process that is difficult to monitor.

d) Responsibilities of manufacturers and app store operators

It is almost hopeless to hold app store operators responsible for compliance with medical device regulations. Responsibility, therefore, remains with the manufacturers, e.g., that

• only medical devices that meet the regulatory requirements are placed on the market,
• medical devices that do not meet these requirements can be withdrawn from the market,
• the users of the medical devices are informed about the measures to be taken.

e) Geographical limitation of placing on the market

By choosing country-specific app stores, manufacturers can usually sufficiently restrict the placement on the market of their devices. For example, a German authority will not act if a medical app is listed in a US store but has not been registered with the authority.

Manufacturers must implement further spatial and temporal restrictions in the app itself. For example, they can require users to identify themselves or register first. Each time the app is started, it checks whether the requirements for its use are (still) met. This makes it impossible to use the app anonymously.

f) Changes due to the MDR, transition periods (for software)

i) Placing on the market versus putting into service

As already mentioned, Article 5 of the MDR requires that devices placed on the market and put into service must comply with the requirements of the regulation. As also already described, the placement on the app store generally counts as placing on the market as soon as a transfer of rights has taken place (e.g., through the purchase by a user). But what corresponds to putting into service? The MDR defines this term as follows:

Many notified bodies and the Johner Institute agree that downloading and installing an app is the same as putting it into service.

ii) Are class I apps expected to remain in the app store indefinitely?

Article 120 of the MDR allows class I devices to be put into service indefinitely:

“(4) Devices lawfully placed on the market pursuant to Directives 90/385/EEC and 93/42/EEC prior to 26 May 2021, and devices lawfully placed on the market from 26 May 2021 pursuant to paragraphs 3, 3a, 3b and 3f of this Article, may continue to be made available on the market or put into service.”’

This means that apps that were added to the app store before May 25, 2021, can remain there indefinitely.

iii) Too early to jump for joy?

Most notified bodies follow the interpretation of the terms “placing on the market” (uploading or releasing in the app store) and “putting into service” (downloading or installing the app from the app store).

One notified body considers the app provision after May 25, 2021 to be illegal! It argues as follows:

The MDR applies from May 26, 2021 (see MDR Article 123), and the EU directives will thus become invalid (see MDR Article 122). This means that devices must comply with the requirements of the MDR from this date.

Manufacturers are responsible for their products and have the necessary regulatory knowledge. Even if a device in the store formally fulfills the criteria for placing on the market, the process of putting into service is still illegal, as the device does not meet the requirements of the MDR at this point in time. The fact that it complied with the MDD requirements before the transition period’s end is irrelevant.

As it can be assumed that the user is unaware of these legal subtleties, the manufacturer is guilty of aiding and abetting an illegal act if it does not remove these devices from the store. This is because they are not preventing devices from being put into operation illegally. In addition, the statements on product liability, such as the infamous Honda ruling, must be observed.

iv) Evaluation of the Johner Institute

The Johner Institute does not follow the argumentation of this notified body at a crucial point:

Legacy devices of class I do not even have to meet the MDR requirements of the MDR. This is exactly what Article 120, Section 4 says (see above). As a manufacturer, you should be prepared for the arguments.

Nevertheless, the discussion is likely to be largely theoretical. After all, it is difficult for an app to remain unchanged in the app store for a long period of time:

1. The manufacturer must meet IT security requirements. It is likely that they will have to update their software and replace libraries (SOUP).
2. App store operators force manufacturers to regularly adapt their software to the latest operating systems.
3. Software that is not further developed dies.

The approach of declaring patches as “maintenance” also has its pitfalls: In the app stores, it is generally not possible to distinguish whether an app is being downloaded for the first time or as an update (patch).

Manufacturers are therefore advised to successively comply with the requirements of the MDR, in particular, to collect clinical data, continuously improve IT security and design, and implement post-market processes in compliance with the MDR.

5. Support for placing on the market

The Johner Institute supports manufacturers in placing devices on the market:

• Determining the regulatory strategy, especially if devices are to be marketed in several countries
• Qualification and classification of devices
• Preparing and reviewing technical documentation
• Creating and examining QM systems
• Inspection of devices, e.g., with usability tests, penetration tests, biological, and electrical safety tests

Please feel free to contact us, e.g., via the contact form.

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Change history

• 2023-11-23: Removal of invalid references to the MPG, among others. Adaptation to the new transitional provisions under the MDR and to the EU Blue Guide 2022.
• 2023-09-04: Question about placing on the market at GitHub (in chapter 2.c) added
• 2023-02-24: Update including the new transitional periods of the MDR
• 2019-07-03: First version of the article