Implementing Regulation (EU) 2017/746 of 5 April 2017 on In vitro Diagnostic Medical Devices (IVDR) in Medical Laboratories, especially in Ophthalmopathology

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 manufacturer's 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-BAK 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.