Abstract
The European Commission revised Directive 98/79/EC on in vitro diagnostic medical
devices (IVDD) to improve patient safety and take appropriate account of technical
progress. With the new
Regulation (EU) 2017/746 of April 5, 2017 on in vitro diagnostic medical devices
(IVDR), high standards for the quality and safety of in vitro diagnostic medical devices
(IVD) apply within
the European Union. The IVDR is primarily aimed at manufacturers and suppliers
of IVDs, but also has significant implications for medical diagnostic laboratories.
Its application is
mandatory as of May 26, 2022. IVD are classified into four risk classes A to
D according to their intended purpose and the associated risks. For the first time,
EU-wide legal requirements
are formulated for products manufactured in-house. Any medical laboratory that
uses “laboratory-developed tests” (LDT), or modifies or uses CE-IVD products outside
the manufacturerʼs
specifications, becomes a manufacturer itself and IVDR Article 5 (5) applies
in its entirety. Production and use of LDT must then be performed within the framework
of appropriate QM systems.
The health care facility must comply with certain provisions (standards), in
Germany the Rili-BÄK is to be mentioned here. LDT are subject to the safety and performance
requirements listed
in Annex 1 to the IVDR, including the requirement for validation prior to first
use, while commercial CE-IVD products only require verification. Regulation (EU) 2022/112
of January 25, 2022,
provides for staggered transition periods of up to six years for some of these
requirements, but it is expected that many laboratories will switch from LDT to commercial
CE-marked IVD
products because ultimately this will be more resource-efficient for them. In
this article, we describe the requirements for medical diagnostic laboratories resulting
from the IVDR and offer
solution concepts for their implementation in smaller, especially ophthalmopathology
laboratories.
Key words IVDR - medical laboratory - ophthalmopathology - in vitro diagnostics - LDT - diagnostic
assays
