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ratories that use IVD medical devices, an examination such as recently through the so-called “Proposed LDT
procedure for an analyte in a biological sample is com- Rule” of the U.S. FDA [14] – ISO standardization efforts
monly referred to as an analytical method, analytical for in-house IVD should be considered. The currently
procedure, or test procedure” [7]. This also confirms developed standard EN ISO 5649 “Medical laborato-
that IVDs can have both object-related and procedu- ries - Concepts and specifications for the design, de-
ral dimensions [8]. The view sometimes expressed that velopment, implementation, and use of laboratory-de-
the regulation of in-house IVDs would not fall under veloped tests” [15] contains an internationally agreed
the responsibility or mandate of the EU, but should be definition of “laboratory-developed tests” and consi-
performed by the national medical professions, must ders various scenarios for in-house IVD. Among others,
therefore be viewed critically [9]. According to Article the draft standard offers clarification on the question
168 (7) of the Treaty on the Functioning of the Europe- to which extent changes to commercially available test
an Union, the individual EU member states are respon- systems lead to in-house IVDs and thus to requirements
sible for determining their health policy, as well as for for these test systems. It remains to be seen whether
the organization of the health system and medical care this standard will provide a useful addition to regulatory
[10]. This includes, for example, the implementation of guidance in practice.
diagnostic procedures and medical laboratory exami-
nations by qualified personnel. But according to Article
168 (4) of the Treaty, the EU has the responsibility and Conclusion
task of contributing to ensuring a high level of health
protection through “measures setting high standards of European and worldwide efforts to strengthen regu-
quality and safety for medicinal products and devices lation and standardization for in-house IVDs are signifi-
for medical use”. Of course, this also includes “in-hou- cantly increasing. On the one hand, the goal of patient
se IVDs”. safety and patient protection may require a sensible set
Apart from MDCG 2023-1, the competent authori- of regulations for this area of medical laboratory testing;
ties of EU Member States have so far communicated on the other hand, such regulations must not hinder the
only few guidance on the interpretation and implemen- innovative capacity and flexibility of medical laboratories
tation of the IVDR requirements under Article 5 (5). Only with regard to the selection and use of examination pro-
the British authority MHRA developed a position pa- cedures in which in-house IVDs play a key factor. This
per for Northern Ireland in January 2022 [11]; the Irish would ultimately torpedo the goal of patient protection.
Authority HPRA is now following this example with a
document presented for consultation in February 2024
[12]. In the latter document, the controversy surroun- References
ding the relevance of the EN ISO 15189 standard is
taken up again. While MDCG 2023-1 states that a labo- 1. (EU) 2017/746 of the European Parliament and of the
Council of 5 April 2017 on in vitro Regulation diagnostic
ratory's sole compliance with the EN ISO 15189 stan- medical devices and repealing Directive 98/79/EC and
dard does not constitute an appropriate quality ma- Commission Decision 2010/227/EU. [odkaz]
nagement system for the manufacture of in-house IVDs, 2. Bank, P. C. D. et al. The end of the laboratory developed
as this area is not within the scope of EN ISO 15189, test as we know it? Recommendations from a national
the medical laboratory community is of the opinion that multidisciplinary taskforce of laboratory specialists on
EN ISO 15189 is fully sufficient [13]. The Irish draft gui- the interpretation of the IVDR and its complications. Clin.
dance requires, firstly, laboratory compliance with EN Chem. Lab. Med., 2021, 59 (3), 491-497. [odkaz]
ISO 15189 (with or without accreditation) and secondly, 3. Hoffmüller, P. et al. Advisory opinion of the AWMF
Ad hoc Commision In-vitro Diagnostic Medical Devices.
a healthcare facility quality management system cove- Advisory opinion of the AWMF Ad hoc Commission
ring the manufacture and use of in-house products. In-vitro Diagnostic Medical Devices regarding in-vitro
At the European level, it is expected in the future diagnostic medical devices manufactured and used
that the problem of the use of so-called “Research Use only within health institutions established in the Union
Only” (RUO) products will be addressed by the Medical according to Regulation (EU) 2017/746 (IVDR). GMS
Devices Coordination Group as part of a new MDCG Ger. Med. Sci., 2021, 19, Doc08. [odkaz]
edition of the former MEDDEV guideline MEDDEV 4. Spitzenberger, F. et al. Laboratory-developed tests:
2.14/2 rev.1 from 2004 “IVD GUIDANCE: Research Use design of a Regulatory Strategy in compliance with the
international state-of-the-art and the regulation (EU)
Only products - A Guide for Manufacturers and Notified 2017/746 (EU IVDR [in vitro diagnostic medical device
Bodies”. RUO products are intended for use in medical regulation]). Ther. Innov. Regul. Sci., 2022, 56(1), 47-64.
research and are often a kind of “intermediate station” [odkaz]
on the way to a commercially available IVD product. 5. Regulation (EU) 2022/112 of the European Parliament
However, they are also used by medical laboratories and of the Council of 25 January 2022 amending
as a basis for the development and manufacture of in- Regulation (EU) 2017/746 as regards transitional
-house IVDs. To date, there is a lack of explanations provisions for certain in vitro diagnostic medical devices
and examples to clearly distinguish RUO and in-house and the deferred application of conditions for in-house
devices. [odkaz]
products from the so-called “products for general labo- 6. Medical Devices Coordination Group Document
ratory use”. Guidance on the health institution exemption under
Against the background of not only European but Article 5(5) of Regulation (EU) 2017/745 and Regulation
also international intentions to regulate the LDT sector - MDCG 2023-1: (EU) 2017/746; January 2023. [odkaz]

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