We are currently being audited so I asked our NB Auditor, and they stated it must be out of your hands completely (invoiced) AND must be in Europe (no longer allowed to import).
That is quite an interesting view on this matter. Taking a look at example 1 of chapter 2.12. of the blue guide:
An X-ray machine manufactured in the USA that has been sold to a hospital in the Netherlands on 15 March 2019 but will only arrive at Dutch customs on 5 April 2019. The product is sold by the manufacturer outside the EU directly to the EU customer via distance sales.
In this case, the date of placing on the market of the X-ray machine is 15 March 2019. This is the date in which a product already manufactured was bought from a manufacturer outside the EU by an EU end user, the order was placed and accepted of a product ready to be shipped. (See Section 2.4. Making available and placing on the market in case of distance and online sales)
Products not yet on EU soil can already have been placed on the market and are therefore eligible for for putting into service or further making available on the market. I do not see the legal tools to stop these products in customs.
On the other hand, when a product is considered as being placed on the market, especially in case of distance and online sales, is worthy of a lot of discussion. Chapter 2.4. of the blue guide states:
Products offered for sale online or through other means of distance sales are deemed to be made available on the Union market if the offer is targeted at end users in the Union. [...] An offer for sale is considered to be targeted at end users in the Union if the relevant economic operator directs, by any means, its activities to a Member State. [...] When an online interface provides for delivery in the EU, accepts payment by EU consumers/end-users and uses EU languages, then it can be considered that the operator has expressly chosen to supply products to EU consumers or other end-users.
Here, the obvious intention seems to be enabling European authorities to intervene against online sellers as early and as close to the root as possible. Therefore, they defined the term "placing on the market" to be that early in the supply chain, i.e. the product is placed on the market as soon as it is offered on the website (and the website has certain characteristics). Considering that a product can only be placed on the market once it is finished, it could be concluded that a device that has left the production and is made available for sale online (offer) can be considered as placed on the market.
In the upcoming circumstances, some entities would like to push the timing of the placing on the market rather to the end of supply chain to ensure as many devices as possible comply with the new regulatory framework for these devices. Some try to argue about property rights and that is another discussion on its own, see
this blog post.
But this is not how legislation is supposed to work. Only one interpretation can be true. Looking at the same supply chain within the context of
the New Legislative Framework, the moment of placing on the market must always be the same. The change of a lex specialis cannot impact this moment unless it changes the definition of "placing on the market".
