That is the question. It is in fact on of the core questions of the three medical devices directives (the Medical Devices Directive, the In Vitro Diagnostics Directive and the Active Implantable Medical Devices Directive), which make the crucial acts of “placing on the market” and “putting into service” subject to compliance with the regulatory requirements under these directives.
With very little publicity (I saw a link under the News heading on the DG Consumer Affairs website to it only on 29/11/2010) the Commission published a new interpretative document on “Placing on the market of medical devices” dated 16/11/2010.
This document is very important for any medical devices company. The document discusses how the definition of “placing on the market” in the three directives must be interpreted by reference to English, German and French language versions of the directives and subsequently with a lot of references to the new market surveillance rules as well as old CE marking acquis when there is placing on the market in two scenarios that are treated very distinctly by the Commission:
- the manufacturer is established in the EU (points 8-14); and
- the medical devices are manufactured outside the EU and subsequently imported (points 15-18).
It also discusses import of devices by private persons for personal use (point 19); rather obviously that does not count as placing on the market.
While the document allows for considerable flexibility for a manufacturer based in the EU to play with the moment when a medical device is placed on the market, such flexibility does not seem to be allowed for devices manufactured outside the EU and subsequently imported into the EU. For EU manufacturers a product is considered placed on the market:
“(10) […] when the product is transferred from the stage of manufacture with the intention of distribution or use on the Community market. Even though the term “transfer” is not used in the legal definition, the German term “Überlassung” in the definition of Inverkehrbringen as well as the term “supply” in the definition of making available (like “Abgabe” in Bereitstellung or “fourniture” in mise à disposition) underline that a certain type of transfer needs to take place.
(11) The transfer can consist in a physical hand-over and/or be based on a legal transaction. It can relate to the ownership, the possession or any other right transferred from the manufacturer to a distributor or to the end user. A transfer of a product is considered to have taken place, e.g., when it is sold, leased, given as a gift, rent out or hired. Where a manufacture operates an own distinct distribution chain, the transfer can also occur to that distribution chain.”
For imported products on the other hand
“(15) […] they must at least be released for free circulation in the internal market before they can be considered as being placed on the EU market (see Articles 27-29 of Regulation (EC) No 765/2008).” and “(17) […] If the transfer of the finished device from the manufacturer (or a distributor) established outside the EU to the importer takes place prior to or during the customs procedure, its release for free circulation will also be the moment of its placing on the market.”
Although the Commission refers to the Blue Guide in point 10 of the document, it is remarkable how well this corresponds with the European Court’s view of the concept of what placing a product on the market for the purpose of the interpretation of the EU product liability directive in the O’Byrne case. In that case the European Court spent quite some words defining where production ends and distribution begins in a complex multinational undertaking in which several subsidiaries are involved in the manufacturing process of a medicinal product.
In my view the interpretative document has the important – and perhaps unintended – possible consequence that advertising of a non-CE marked medical device does not constitute (or may likely not constitute) placing on the market of that medical device. Some have argued that medical devices must be CE compliant before any ‘offer to transfer’ may be made or before they can promoted lawfully on the EU market, by reference to the MDD or IVDD only. If we look at the interpretative document however the Commission fixates on the actual placing on the market (and not just advertising that this may happen at some point in time when CE marking has been completed). This actual placing on the market is defined as a physical act or legal transaction-based handover pursuant to which a device is transferred from the stage of manufacture with the intention of distribution on the EU market (see points 10 and 11). In my opinion a promotional announcement that a particular device is in the pipeline but is not yet available because the regulatory process is not yet completed does not constitute ‘placing on the market’ under the theory of the interpretative document. This would also fit in with the exception provided for in article 4 (3) of the MDD (the trade fair exemption), because this provision aims to create an exemption for advertising of a device that is not yet CE marked, “provided that a visible sign clearly indicates that such devices cannot be marketed or put into service until they have been made to comply”. In other words, no misleading of the public about the regulatory status of the advertised device. This may be extrapolated to other forms of publicity, since the MDD does not limit this exemption to trade fairs only (it rather gives a non-exhaustive list of ways to advertise a device: “trade fairs, exhibitions, demonstrations, etc.”). I am aware that this interpretation may seem very controversial, but it can be defended under the concept of placing on the market as clarified by the Commission in the interpretative document. Before you get your hopes up as manufacturers and distributors: don’t forget also that there may be national law in EU member states that regulates advertising of non-CE marked devices. However, insofar as that would go contrary to the MDD under in the interpretation defended here, it is contrary to EU and should not be enforced. A lot more can be said about this. Discussion, anyone?