Post by Peter Lotz, M.C.J. (NYU) Attorney, Attorney-At-Law (N.Y.) MAYRFELD LLP

Do you have the logistics in place? All set with the transitional periods? All set on the UDI? A primer.

On 5 April 2017 the European Parliament adopted its new EU-Regulation for in-vitro Diagnostics (Regulation (EU) 2017/746 on in vitro diagnostic medical devices and repealing Directive 98/97/EC and Commission Decision 2010/227/EU, the “IVDR”), which will bring about massive changes to the existing regulatory framework for market entry of IVD in the EU. The IVDR replaces the currently existing EU Directive on In-vitro-Diagnostics (98/79/EG) in its entirety. The final version of the IVDR was published on May 5, 2017 and entered into force 20 days later. The provisions of the IVDR apply from May 26, 2020. Save certain transitional rights provided by the regulation, manufacturers of IVD now have roughly three years to adapt their internal processes and to obtain a re-certification of their currently available IVD in accordance with the new provisions of the IVDR .

Following is a first overview on the major changes provided by the IVDR – in particular, our observations to certain inconsistencies of the transitional provisions may be of interest. We will go into further detail on individual aspects of the IVDR in later articles.

Scope of the IVDR

In comparison to Directive 98/79/EC (the “IVD Directive”), the scope of product coverage is greatly increased and in the future also comprises, including, without limitation, high risk products that are manufactured and used in the same health care facility, IVD for diagnostic applications over the Internet, as well as applications for genetic analysis and other tests on a patient’s specific predispositions regarding specific diseases or the efficacy of a specific medical treatment.

New classification system

The IVDR introduces a new risk based classification system on the basis of principles developed by the Global Harmonization Task Force. The classification system comprises risk classes A to D, whereas products with low risk are allocated to class A and products with the highest risk are allocated to class D. The IVDR does not provide for lists assigning classes to certain types of products, however, in its Annex VIII sets forth seven rules for the appropriate classification of products in compliance with the IVDR.

Identifcation of a (qualified) responsible person

Similarly to pharmaceutical companies, manufacturers of IVD products now are obligated to identify a responsible person, who eventually is responsible for the manufacturer’s compliance with the requirements set forth by the IVDR. Moreover, manufacturers are obligated to demonstrate that the responsible person is sufficiently qualified for taking over this responsibility.

Increased involvement of Notified Body

Given the introduction of the new risk based classification system, it is not unlikely that – with the exception of class A products – the conformity assessment for medical products will require the involvement of a Notified Body. Certain sources expect that in the future the conformity assessment of 70% of all IVD will require the involvement of Notified Bodies.

Introduction of unique device identification

The IVDR requires each manufacturer of IVD to assign a so-called unique device identification to each manufactured product so that products that impose a risk can be better tracked down the supply chain for purposes of a recall.

More stringent requirements regarding technical documentation and clinical evidence

In comparison to the IVD-Directive, the IVDR imposes more stringent documentation requirements. The IVDR requires manufacturers to demonstrate performance and safety of a product in accordance with its risk classification by data derived from clinical studies. Further, manufacturers are obligated to conduct a continuous safety assessment of their products by collecting and analyzing corresponding clinical data.

Stronger supervision of Notified Bodies

The conformity assessment of high risk products in the future may require the involvement of the competent authorities and reference laboratories. Accordingly, it is expected that conformity assessment proceedings may take longer in the future. Certain sources are concerned that more stringent rules on the designation of a Notified Body may lead to a smaller number of Notified Bodies available for IVD certification.

No grandfathering, transitional provisions, timelines

From a business perspective, one of the most crucial effects of the IVDR is the lack of grandfathering rights. Even devices that currently are lawfully placed on the market pursuant to Directive 98/79/EC, eventually require (new) certification for continued (lawful) marketing under the requirements set forth by the IVDR. Therefore, manufacturers of devices currently available on the market have to obtain a new certification going forward for the the continued marketing of their products within certain transitional periods set forth by the IVDR. In this context, the IVDR’s transitional provisions refer to the existence of certificates pursuant to Directive 98/79/EC for, and the time of marketing of, existing or new devices.

The “Certificate Exception” – reference date 25 May 2017

In a first step, manufacturers need to consider whether a certificate for an existing device was issued prior to or from 25 May 2017: Certificates issued in accordance with Directive 98/79/EC prior to 25 May 2017 shall remain valid until the end of the period indicated on the certificate. This does not apply to certificates issued in accordance with Annex VI (EC Verification) to Directive 98/79/EC: these certificates become void at the latest on 27 May 2024. Certificates issued in accordance with Directive 98/79/EC from 25 May 2017 shall become void by 27 May 2024.

However, notwithstanding the foregoing, from the date of the application of the IVDR (26 May 2020), the IVDR’s provisions regarding post-marketing surveillance, market surveillance, vigilance, registration of economic operators and of devices apply to all devices that are lawfully marketed under the Certificate Exception. The notified body that issued the certificate either prior to or from 25 May 2017 remains responsible for the appropriate surveillance to the devices it has certified.

The “Marketing Exception” – reference date 26 May 2022

In a second step, manufacturers need to observe the provisions of Art. 110(4) IVDR. At least with regard to its English and German versions, however, the language in Article 110(4) IVDR is not consistent. This circumstance poses difficulties on the calculation of the transitional period depending whether the English language version or the German language version of the IVDR is used.

Pursuant to Art. 110(4) IVDR, the above periods under the Certificate Exception may vary depending whether devices pursuant to Directive 98/79/EC are placed on the market on or before 26 May 2022: In any case, devices lawfully placed on the market before 26 May 2022 pursuant to Directive 98/79/EC may continue to be made available on the market until 27 May 2025.

Regarding devices that are placed on the market on or after 26 May 2022, the English and German language versions of the relevant Article 110(4) of the IVDR are not fully consistent: while the German language version of Article 110(4) makes reference to “[…] products placed on the market from 26 May 2022 by virtue of a certificate as referred to in paragraph 2 sub-paragraph 2 of this Article”, the English version of this provision reads “…products placed on the market 26 May 2022 by virtue of a certificate as referred to in paragraph 2 of this Article…” (emphasis by author). The language of both versions, however, does make a not insignificant difference:

(i) Regarding the date a product is placed on the market, the German version clearly provides for a period from 26 May 2022. Therefore, the German version covers products that are placed on the market on as well as after 26 May 2022. However, the language of the English IVDR version printed in the Official Journal “placed on the the market 26 May 2022” is missing a qualification directed towards the future. Therefore, the relevant provision of the English version printed in the Official Journal only covers products that are placed on the market on 26 May 2022 and not thereafter. However, in the IVDR version ratified by the European Parliament and the Council (see p. 258) the relevant provision reads “… devices placed on the market from … [date of application of this Regulation]…” (emphasis by author). Thus, it seems that the English language version of the IVDR ratified by the EP and the Council is not identical with the English language version printed in the Official Journal. On the other hand, regarding the date a product is placed on the market, the German version corresponds to the English language version ratified by the EP and the Council.

(ii) On the other hand, the reference to a certificate issued “… pursuant to paragraph 2 sub-paragraph 2 …” in the German version of Art. 110(4) IVDR is not clear. Both, the ratified English version of the IVDR and its version printed in the Official Journal make reference to a “… certifcate as referred to in paragraph 2 of this Article…”. The English versions do not differnciate between a sub-paragraph 1 or a sub-paragraph 2. Whether that makes sense remains open. A random comparison with the French, Dutch, and Spanish versions shows, however, that these also (only) make reference to “paragraph 2” without distinction as to its sub-paragraphs.

The difference is not really trivial, however, since Art. 110(2) provides for two different issuing dates for certificates: 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 (i.e., either on oder after 25 May 2017). As a result, the German version of Art 110(4) (only) covers products with certificates pursuant to the IVD-Directive issued from 25 May 2017 and which are placed on the market from 26 May 2022. On the contrary, the English language version of Art 110(4) covers products with certificates pursuant to the IVD-Directive issued either prior or after 25 May 2017 (for the lack of a distinction between sub-paragraph 1 and sub-paragraph 2 in the referral to paragraph 2) and which are placed on the market on (i.e. from subject to further clarification in Brussels) 26 May 2022.

Pursuant to the German version of the IVDR the issuing date of a certificate pursuant to the IVD-Directive makes a difference which is not present in the English language version. That may not have been intended. We think that the language in Art 110(4) IVDR of the English version printed in the Official Journal as well as of its German translation urgently require clarification by the competent bodies.

IVDR-compliant devices

Devices which fully comply with the provisions of the IVDR may be placed on the market before 26 May 2022. These devices require certification by a Notified Body that has been designated prior to 26 May 2022 (see below). The same applies to devices that underwent conformity assessment pursuant to Art 48(3) and (4) of the IVDR, provided, that the necessary appointments to the MDCG, expert panels, and of EU reference laboratories have been made.

Compliance of Notified Bodies

Notified Bodies may be designated under the IVDR prior to 26 May 2022. Such Notified Bodies may carry out the conformity procedures and issue certificates pursuant to the IVDR prior 26 May 2022.

Manufacturers will now need to consider setting up the necessary internal and external processes to allow compliance of their products and processes with the new IVDR requirements applicable in 2020 (subject to the above transitional provisions). If you have not already done so, this may be the time to update your QA-system on compliance with the current DIN ISO 13485:2016. You may further want to establish an internal working group comprising of individuals from your development, logistics and production departments for defining a strategy for setting up a consistent UDI within your organization. Of course, manufacturers should now investigate by which classes (A to D) their products are covered. Further, you may want to review your technical documentation policies and post-market-system on any potential gaps in relation to the new requirements set forth by the IVDR. Since all Notified Bodies will require a new designation under the IVDR and since the conformity assessment of a fair number of IVD in the future may require the involvement of a Notified Body, it is expected that these circumstances may lead to delays in conformity assessment proceedings, in particular in connection with the re-certification of products already existing on the market. Therefore, it may be advisable to timely get in touch with your Notified Body to clarify issues of re-certification of your products already available on the market.

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About the author Peter Lotz, M.C.J. (NYU) Attorney, Attorney-At-Law (N.Y.) MAYRFELD LLP
Peter Lotz is a partner of MAYRFELD LLP. He has been counseling for nearly 20 years domestic and foreign Fortune 500 companies as well as SMEs in connection with the cross-border developemt, acquisition, licensing and commercialization of novel technologies.
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