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Klin. Biochem. Metab., 32 (53), 2024, No. 1, p. 4 - 6

Consequences of the EU IVDR implementation for medical
laboratories

Spitzenberger F. 1,2

1 Centre for Regulatory Affairs in Biomedical Sciences, Technische Hochschule Lübeck,
Mönkhofer Weg 239, 23562 Lübeck, Germany
2 Fraunhofer Research Institution for Individualized and Cell-Based Medical Engineering IMTE,
Mönkhofer Weg 239 a, 23562 Lübeck, Germany

With the entry into force of the European Regulation So, it was just right for the medical-scientific socie-
(EU) 2017745 (“IVDR”) on May 26 2022, drastic chan- ties and the laboratories concerned that the amending
th
ges have occurred for practically all stakeholders in Regulation (EU) 2022/112 introduced new transition
the field of in vitro diagnostic medical devices (IVD) [1]. periods for certain requirements, e.g. relating to the QM
Manufacturers are confronted with a new classification system [5]. These transition periods expire on May 26,
concept for their products and, due to the resulting up- 2024 - this year - and on May 26, 2028, respectively.
-classification of products, they have to carry out a sig- If the lack of initiative from the laboratory experts
nificantly more complex conformity assessment proce- with regard to the IVDR requirements can be criticized,
dure for CE marking. Notified bodies face the challenge this is especially true for the positioning of the official
of meeting the designation criteria and providing the ca- committees of the competent authorities. The Euro-
pacity and skills to participate in the conformity assess- pean MDCG guideline MDCG 2023-1 “Guidance on
ment procedures. Member State competent authori- the health institution exemption under Article 5(5) of Re-
ties often struggle with interpreting market surveillance gulation (EU) 2017/745 and Regulation (EU) 2017/746”
requirements and implementing their diverse tasks. was only published five and a half years after the IVDR
Medical laboratories represent stakeholders who, came into force and after extremely controversial dis-
with the IVDR, are directly affected by European legis- cussions between industry, authority, and laboratory
lation in the IVD product sector for the first time. This is representatives [6].
because medical laboratories are either health facilities This guideline, however, clarifies the scope of Ar-
themselves or are part of health facilities to which Artic- ticle 5 (5). The IVDR does not define a special term for
le 5 (5) of the IVDR can apply. This section of the IVDR IVDs manufactured in-house, but rather speaks of “pro-
always applies when IVDs from in-house production ducts”. According to MDCG 2023-1, the definitions in
(so-called “in-house IVDs”, borrowed from Anglo-Ame- accordance with Article 2, No. 2 of the IVDR apply to
rican parlance also known as “Laboratory-Developed these “products”. Accordingly, these products include,
Tests-LDT”) are manufactured and used within a labo- e.g., reagents, calibrators, control materials, devices,
ratory without this be placed on the market. Although software, and systems which, whether used alone or in
the IVDR does not apply to these products as a who- combination, are intended for the in vitro examination of
le, certain conditions must still be met as basic requi- specimens derived from the human body. According to
rements by the relevant health facilities or the health MDCG 2023-1, the products addressed under Article
facility laboratories. This includes, among other things, 5 (5) IVDR also include so-called “accessories” that
compliance with the applicable general safety and per- meet the definition according to Article 2, No. 4 of the
formance requirements according to Annex I of the IVDR. The “manufacture and use” of such devices refer-
IVDR and associated documentation, the implemen- red to in Article 5 (5) of the IVDR, according to the in-
tation of an appropriate quality management system, terpretation of the MDCG Guide, includes various types

a declaration of conformity of the in-house products, of combination and modifications of devices with the
and a justification for the use of the in-house products aim of use in in vitro diagnostic testing. However, the
compared to with test systems that may be commercial- in-house products referred to in Article 5 (5) do not in-
ly available on the EU market. clude sample materials and reports, nor standard ope-
The European and national medical-scientific so- rating procedures (SOPs) or implementation protocols.
cieties were initially completely unaware of the integra- However, the latter may be necessary for the use of
tion of these requirements into a legal regulation that the “products” and should therefore comply with the
constitutes direct law for all EU Member states and of applicable requirements set out in Chapter III of Annex I
their consequences for medical laboratory diagnostics. of the IVDR.
Only three to four years after the IVDR came into for- In accordance with this, the standard EN ISO
ce that the first publications appeared that made clear 15189:2023, Section 3.9 defines an examination pro-
the urgent need for action to interpret the IVDR require- cedure as a “specifically described set of operations
ments for in-house IVDs and the qualitative and quanti- used in the performance of an examination... according
tative significance of in-house IVDs for patient diagnos- to a given method”. Note 1 to the term further clarifies:
tics [2-4]. “In the IVD medical device industry and in many labo-

4 Klinická biochemie a metabolismus 1/2024