EU-IVDR: Transitional Provisions

The EU-IVDR “lost in translation”? A comparison of the transitional provisions.

The new EU-IVDR’s transitional provisions are tricky. However, a comparison between the ratified and the published English version, and the German version shows two inconsistencies that companies need to be aware of.

In our blog post of July 7, 2017 providing an overview on the new EU IVD-Regulation we already pointed out the inconsistencies between the ratified English version of the IVDR and the English version published in the Official Journal. Further, there are inconsistencies in the German translation of the ratified English version. With this article, we want to highlight the differences once more and explain whether and to which extent they are relevant in the practical application of the IVDR’s transitional provisions.

The Basic Principle

Although all IVDs on the market need to be re-certified upon the IVDR getting effective (May 26, 2022), the IVDR provides certain transitional rights allowing manufacturers to market IVD certified under Directive 98/79/EC even after the effective date of the IVDR. Basically, two factors have to be considered: (i) whether your IVD was certified pursuant to Directive 98/79/EC prior or from May 25, 2017 and (ii) whether your certified product is placed on the market either prior or from May 26, 2022.

As you can take from the graph below, the Commission limited the lifetime of certificates issued by a notified body pursuant to Directive 98/79/EC on the one hand (green arrows) and, on the other hand, limited the period during which products with such certifications can be placed on the market without re-certification pursuant to the IVDR. As a result, manufacturers first need to figure out when a certificate was issued by a Notified Body pursuant to Directive 98/79/EC (a “Certificate”): It may have been issued prior to May 25, 2017 (see Art. 101 Sec 2 Subsection 1), or it may have been issued from 25 May 2017 (see Art. 101 Sec 2 Subsection 2).

In addition, a manufacturer has to consider whether its existing IVD product (certified with one of the Certificates mentioned above) is/has been placed on the market prior or from May 26, 2022. Now, there are several combinations possible. However, when comparing the different language versions of the IVDR, its English and German translations seem to put further limitations on the combinations set forth in the ratified version of the IVDR.

Inconsistencies In The Published English Version

The provision at issue is Article 110 Section 4 of the IVDR. In the version of the IVDR ratified by the European Parliament and the Council (see p. 258) the provision reads:

“Devices lawfully placed on the market pursuant to Directive 98/79/EC prior to …[the date of application of this Regulation] and devices placed on the market from … [date of application of this Regulation] by virtue of a certificate as referred to in paragraph 2 of this Article, may continue to be made available on the market or put into service until … [three years after the date of application of this Regulation]”. (emphasis by author).

However, Article 110(4) of the IVDR’s English language version published in the Official Journal reads:

“Devices lawfully placed on the market pursuant to Directive 98/79/EC prior to 26 May 2022 and devices placed on the market 26 May 2022 by virtue of a certificate as referred to in paragraph 2 of this Article, may continue to be made available on the market or put into service until 27 May 2025.”

As you can see, the IVDR’s Article 110(4) published in the Official Journal is missing the word “from” in the relevant sentence.

Does it make a difference? We think it does. Strictly speaking Article 110(4) as printed in the Official Journal (that is the legally binding version) does not allow to place devices with a certificate pursuant to Directive 98/79/EC on the market after 26 May 2022. This is a not insignificant limitation of rights compared to the rights granted in the ratified version. In addition, it does not reflect the European Parliament’s and the Council’s intentions upon ratification. Obviously, the word “from” got lost on the IVDR’s way from the parliament to the printer (a phenomenon that most finance lawyers checking prospectuses at a printing press may have experienced the one or the other way during their career). Nonetheless, we think this error should be fixed and the market participants need to know about it.

Inconsistencies With The German Translation

Going a little further in the same sentence, the German translators added some language to Article 110(4) that is not present in the ratified version of the IVDR. Article 110(4) in the ratified version of the IVDR in pertinent part reads as follows:

“[..]and devices placed on the market from … [date of application of this Regulation] by virtue of a certificate as referred to in paragraph 2 of this Article [..]” (emphasis by author).

In the IVDR’s German version this sentence is translated as follows:

“[..]and devices placed on the market from … [date of application of this Regulation] by virtue of a certificate as referred to in paragraph 2 subparagraph 2 of this Article [..]” (emphasis by author – for the reader’s convenience re-translated in the English language).

Clearly, the German translators narrowed the reference to paragraph 2 to paragraph 2 sub-paragraph 2. In this context it is of interest that Article 110(2) actually provides for a sub-paragraph 1 and a sub-paragraph 2. Art. 110(2) sub-paragraph 1 covers products with certificates issued pursuant to the IVD-Directive prior to 25 May 2017. Art. 110(2) sub-paragraph 2 covers products with certificates pursuant to the IVD-Directive issued from 25 May 2017. As a result, the German version of Art 110(4) limits the transitional rights to products with certificates pursuant to the IVD-Directive issued from 25 May 2017 and which are placed on the market from 26 May 2022. Technically, contrary to the ratified version, products with certificats issued prior 25 May 2017 and placed on the market from 26 May 2022 are not covered.

Does it make a difference? Well, for sure it does not conform with the language of the ratified version. Personally, I would not want to read language in a German translation that is not contained in the original version. Does it put manufacturers that apply the German version at a disadvantage? Not necessarily, if you take a closer look at Article 9 Section 10 of Directive 98/79/EC providing that certficates issued by Notified Bodies pursuant to the Directive’s Annexes III, IV and V shall be valid for a maximum of five years, and – upon request – can be renewed by another five years. Therefore, if a certificate has been issued on 24 May 2017 (i.e. prior to 25 May 2017), this certificate iIn any case will expire prior to 26 May 2022. As a result, it would not be possible to place a product on the market from 26 May 2022 on if such product has been certified prior to 25 May 2017.

Thus, the reference to “subsection 2” in Article 101(4) of the IVDR’s ratified version (and in all other languages we checked) actually is imprecise, since a certificate pursuant to Directive 98/79/EC issued prior to 25 May 2017 (see Article 110 Section 2 Sub-Section 1), pursuant to Article 9(10) of Directive 98/79/EC will have expired before 26 May 2022, so that no product can be placed on the market from 26 May 2022 on the basis of such certificate (i.e., a certificate pursuant to Article 110 Section 2 Sub-Section 1). Therefore, it is actually much clearer to refer to “paragraph 2 sub-paragraph 2 of this Article”. However, I am wondering whether it should be the job of the legal translators to provide for this clarity or whether it would be better to include this clarification in the official version and in all translations of the IVDR.