After my blog about guidance document MDCG 2021-27 in which I argued why in my view it defines placing on the market wrongly by requiring transfer of a property right as a condition for placing on the market, a lot of discussion started.
I even received an email from the European Commission commenting on the blog post, explaining that the idea with MDCG 2021-27 was not to make any changes to any existing interpretation of the concept of placing on the market in existing guidance (and, by the way, that the importer double check with the manufacturer in case of re-importation under question 7 that I criticized as a new obligation was meant as a suggestion, not as a new obligation).
There were also people that helpfully informed me that the Blue Guide literally uses the words ‘property right’ in relation to placing on the market, so what was my problem? Some of them also defended the theory that it was only appropriate that (contrary to making available) placing on the market as a first logistic step into the Union would comprise a change of title/ownership but did not provide a good argument for why it would be appropriate – so my inner Shania Twain was not yet impressed.
Still, I could not parse why the concept of making available, which is nested in the concept of placing on the market, should be interpreted differently depending on the economic operator. I cannot find a good reason why ‘any (other) property right’ should be transferred to an importer, while ‘any (other) right’ would do for a transfer to a distributor. That just did not make sense to me.
I had not read the Blue Guide often enough – in other languages
Have I ever mentioned how much, in my experience, speaking several languages enriches my experience of the world? I am fluent in quite a few languages and can get by passively in a number of others. Suddenly it hit me: whenever someone says it’s in the text, better check if it’s in the text in all language versions of the text. In the EU we proceed from the principle that all languages in which official documents are available are equally important. So it may well be that the English text that most people seem to read as only source may actually not represent the guidance intended to be given by the Commission correctly.
And there we had it: I always tease people that they should read the Blue Guide more and then realized that I myself had only ever read it in English – clearly I had not read it enough myself either – not in enough languages! So I started checking languages within my command and quickly found out that the French and German versions of the Blue Guide indeed are phrased differently as to NOT require transfer of a property right for placing on the market.
See for yourself:
The German version of the Blue Guide formulates the sentence in the English version that contains the requirement of ‘any other property right’ as follows:
“Das Inverkehrbringen eines Produkts setzt ein Angebot oder eine (schriftliche oder mündliche) Vereinbarung zwischen zwei oder mehr juristischen oder natürlichen Personen in Bezug auf die Übertragung des Eigentums, des Besitzes oder sonstiger Rechte hinsichtlich des betreffenden Produkts nach dessen Herstellung voraus.” (emphasis added)Blue Guide 2016 – German, section 2.3, 3rd paragraph
The French version formulates the same sentence as follows:
“La mise sur le marché d’un produit exige une offre ou un accord (écrit ou verbal) entre deux ou plusieurs personnes physiques ou morales en vue du transfert de la propriété, de la possession ou de tout autre droit concernant le produit en cause après la phase de fabrication.” (emphasis added)Blue Guide 2016 – French, section 2.3, 3rd paragraph
As is evident from the above quotes in German and in French, neither of these versions of the text requires transfer of a ‘property’ right because both unambiguously speak about ‘any other right’. That is literally what “sonstige Rechte” and “toute autre droit” mean.
And this is fully consistent with how the Blue Guide defines making available, making the Blue Guide texts in French and German fully logically coherent.
As I checked more languages I found that also the Swedish version does not require a property right transfer either (“någon annan rättighet”, which also literally means ‘any other right’). But the Dutch, Italian and Spanish ones do refer to property right in this context.
CE in action – Confusion Everywhere! So now what – Germans, Swedes and French crazy? Others crazy? Who to believe?
European Court to the rescue
The European Court of Justice (CJEU) has seen issues like this before, because the EU translates a lot of documentation in a lot of languages, so inconsistencies are bound to arise occasionally, even though we have fantastic translation processes with extremely highly qualified translators that translate texts in the weirdest language combinations. A hat tip to you, dear EU institution translators! Your work preserves the treasure of European linguistic diversity and the cultural heritage associated. Too often I hear people speaking only one language say that all these different languages make things too complicated – I vehemently disagree with that. But I digress.
So how do we solve this pu
zzle of interpretation? The CJEU comes to the rescue. It has helpfully ruled in its case law (see for example C-558/11 Kurcums Metal ECLI:EU:C:2012:721 (para. 48)) that if language versions of a given EU text differ, you cannot automatically assume that one of them is correct and the other is wrong – there is no trump language for any official document. Or in the wording of the CJEU:
“It is settled case‑law that the wording used in one language version of a provision of European Union law cannot serve as the sole basis for the interpretation of that provision, or be made to override the other language versions in that regard. Such an approach would be incompatible with the requirement for uniform application of European Union law.”C-558/11 Kurcums Metal, para 48
This is very logical indeed because no language is more important than another. So in our puzzle we have English version (and some others) versus German and French versions (and some others). In that case, the CJEU says, you need to chose the interpretation that best reconciles the text and purpose of the rules concerned. Or, as the CJEU puts it
“Where there is a divergence between the various language versions, the provision in question must thus be interpreted by reference to the general scheme and the purpose of the rules of which it forms part.”C-558/11 Kurcums Metal, para 48
Obviously, (as I have defended in my previous blog) the most logical interpretation and the one best fitting the logic and meaning of the New Legislative Framework legislation described in the Blue Guide is that the definition of the MDR and IVDR defined concept of making available is interpreted consistently between its use as a standalone concept and its use as element of the MDR and IVDR defined concept placing on the market. Unless someone has a convincing argument about why this should not be the case and a reason why we do need a property right for placing on the market for an unknown reason – so far I have not seen any convincing arguments to that effect. The Commission seemed to agree with me on this point, stating to me that the definitions in the Blue Guide as such are not fully congruent.
Blue Guide may still be amended for this
The good news is that the 2016 version of the Blue Guide is (still) under revision, so this point can (still) be taken on board by the Commission in the revision process. Call me a silly nitpicker but I think it’s always a good idea that one of the crucial concepts of a broad legislative framework like the NLF is explained consistently in a crucial guide document and moreover in the same way in all language versions. If the Commission indeed decides to amend the Blue Guide on this point, there is no reason not to also amend 2021-27 to account for this as well – this is by the way also what the Commission told me that they indeed intend to do if the Blue Guide is amended this way. In the mean time, in my view, industry can rely on the interpretation offered by me based on the incongruence between language versions, which means that the English version cannot be considered to reflect the guidance given correctly. The French and German version provide (in my view) the better interpretation.
So, we will need to see if the Commission agrees that taking out ‘property’ right should be uncontroversial and the logical choice because it is actually in the Blue Guide already, depending on the language version that you read. My modest suggestion for the next Blue Guide edition: go for the logical interpretation across languages, i.e. making available does not require any ‘property right’ transfer, neither separately nor when nested in the definition of placing on the market.
Why is this so important?
You could wonder why I am making such a fuss out of this. Well, I am doing this because a correct interpretation of the concept of placing on the market is absolutely and utterly crucial for being compliant with the MDR and the IVDR. CE marking legislation revolves around this concept.
For example, the concept determines if a device is covered by a temporal exemption like the grace period under the MDR or not. And now with the amended IVDR (here is my blog about it, adopted version here) the majority if IVDs for the European market are also subject to grace periods. It determines qualification and obligations of economic operators. And much more – just do a search of where placing on the market pops up in the MDR and IVDR – you will be amazed. That’s why its importance for the MDR and IVDR cannot easily be overstated and why it is so important that it is interpreted correctly.
Keep fighting the good fight!
This is awesome. Love the meme too.
Ginger Cantor, MBA, RAC Founder/Principal Consultant Centaur Consulting LLC
On Fri, Feb 18, 2022, 4:13 AM medicaldeviceslegal wrote:
> Erik Vollebregt posted: ” After my blog about guidance document MDCG > 2021-27 in which I argued why in my view it defines placing on the market > wrongly by requiring transfer of a property right as a condition for > placing on the market, a lot of discussion started. I even r” >
Where would we be without good memes, right?
Any updates on the Blue Guide? Do we have any news on when it might be published?
Unfortunately not. We’ve had two not very transparent rounds of consultation but no visibility on when the final version is going to be published.
Hey Erik, was there a Have your say on this? My Google skills have failed me and while I’ve found a few companies who posted their feedback, I never located the place where they sent that feedback. Was this a Have your say initiative? (I tried looking there, too, but again my search skills failed me).
Hi Corey, I don’t think that it was a formal consultation, so it may well be that the reactions are not public.
I have come across a few cases of non-EU manufacturers using a “virtual importer”, i.e. someone who fulfils the role of importer described in the Blue Guide / MDR / IVDR but never actually takes possession of the products (whether literally in their warehouse, or virtually like a sales agent). Sometimes this is a sister company, an EU Rep or a logistics company.
I could never get my head round how this was possible when reading these documents in English and it sounds like you have found the answer! Is it possible, therefore, to confer the “right” to act as an importer on an EU company that never actually handles or invoices for the product? Would that “right” have to be conferred in French or German rather than English?
Ok maybe that last question was a joke… but then maybe not…
Hi Jack, virtual importing is a thing and I myself have advised certain virtual importers about the legal feasibility of this model. Don’t forget that this is exactly how most big multinationals handle this internally, with their own internal service providers being subsidiaries . The MDR and IVDR are agnostic as to whether this happens internally in a group of companies or involves an external company.
Thanks Eric. Is it fair to say that the legal feasibility of the virtual importer model hinges on the interpretation of “any other right”, hence your objection to the inclusion of the word “property” in the middle of that term in the MDCG document?
That is definitely a thing because most companies wouldn’t want to transfer property rights on stock to the virtual importer, nor would the virtual importer want this. Fortunately that’s not required, so the model remains possible,