Want to keep your in-house IVD assay compliant? Be ready with Eurogentec.
Clinical labs often use in-house IVD or Lab Developed Tests (LDTs), when no kit fits their needs and for flexibility. Under IVDR, exemptions require proof of manufacturing reliability and traceability. Outsourcing assay preparation may be a solution to meet compliance while keeping design control.
The situation
As private or hospital diagnostic laboratory, you may offer testing for several hundred targets (e.g. for example, pathogenic targets like bacteria, viruses, parasites...) and routinely rely on qPCR-based in-house IVD or lab-developed tests (LDTs) to cover part of this broad molecular diagnostics portfolio. With the scientific expertise to design these assays in-house, you retain full control over their content and benefit from the flexibility to respond rapidly to local needs and emerging targets.
Nevertheless, as a health institution based in the EU, you're likely familiar with Regulation (EU) 2017/746, commonly known as the In Vitro Diagnostic Regulation (IVDR). This regulation mandates the use of CE-IVD–marked kits whenever a suitable one is commercially available. Although its final implementation deadline continues to be delayed, laboratories like yours are expected to anticipate the transition and prepare accordingly.
The exemption request
In practice, relying exclusively on commercial kits is rarely feasible. A suitable CE-IVD kit may not exist for your target of interest, may lack critical markers (such as newly emerging variants), may have been discontinued, or may not be compatible with your current instrument platform.
In these cases, the IVDR (Chapter II, Article 5.5) allows the continued use of in-house assays, but only under stricter conditions. To keep using your LDTs, you must apply for an exemption, demonstrating that your assay notably complies with the general safety and performance requirements defined in IVDR Annex I, with particular focus on manufacturing reliability and traceability.
This means building a complete and compliant manufacturing file. However, while your lab may already operate under ISO 15189, which provides a robust quality management framework, this standard does not address manufacturing processes, a key requirement under IVDR.
Our solution
One effective way to align your in-house testing with IVDR expectations is to outsource the preparation of your assay into ready-to-use reagent mixes.
This approach allows you to retain control over assay design while delegating the manufacturing steps subject to regulatory scrutiny. It also enables you to benefit from robust documentation, full traceability, and standardized, high-quality production. Most importantly, it helps you address risk mitigation, a core expectation of Annex I, by reducing variability, human error, and inconsistencies that can arise from manual in-house preparation.
Discover how we can help you
On top of supplying qPCR raw materials such as oligonucleotides, plastic consumables, and master mixes, we also offer a custom assay preparation service.
You define your in-house assay content. We handle its preparation in cleanroom.
Browse the 5 ways outsourcing your custom assay manufacturing can simplify your testing workflow and help you meet IVDR expectations.
1. An appropriate Quality Management System
IVDR requires that IVD devices be manufactured under an appropriate quality management system. In line with this, Eurogentec operates under ISO 9001 (general) and ISO 13485 (diagnostic oligo production) certifications. Our processes follow validated SOPs, use version-controlled documentation, and are fully auditable. We set up a comprehensive risk analysis, manage non-conformities, and implement corrective and preventive actions (CAPA) procedures when needed, providing a strong, IVDR-ready foundation for your in-house assay projects.
2.Controlled manufacturing, from design to end-use
Devices must be manufactured under controlled conditions that limit risks at all stages. Accordingly, a dedicated Project Manager oversees your project, validating oligo sequences, reagent concentrations, control strategies and platform compatibility with you. Technical support for assay optimization is also provided if needed. Manufacturing takes place in ISO7 and ISO8 classified clean rooms, using robotic dispensing to ensure reproducibility and minimize the risk of pipetting errors. Assays are delivered in the ready-to-use format of your choice, thereby simplifying handling by end-users and supporting workflow standardization.
3.Proven analytical performance and full documentation
IVDR exemption requires evidence of assay performance, supported by appropriate technical documentation. While clinical validation remains your responsibility, we ensure the analytical quality of both individual reagents (oligos and master mixes) and the final premix. Each batch is subjected to qPCR-based release testing to confirm both the absence of contamination and proper amplification of the internal positive control (IPC). Moreover, additional testing using your own positive controls can be performed in a separate room dedicated to controls. In the end, you receive a signed QC release report for each premix lot, as well as a full documentation package for key raw materials (e.g. oligonucleotides and mastermixes analytical reports, SDS, TDS as well as certificates of analyses depending on oligonucleotide grade), helping you build a complete and documented manufacturing file.
4. Clear traceability and identification
The regulation also states that all details necessary to identify your assay should be provided, to ease identification and avoid misuse, especially in workflows involving multiple assays. To support clear assay identification, we label your assay with all required information such as assay name, lot number, storage conditions, expiry date, and reaction volume. All this information is enclosed in the dedicated validated production file. To prevent mixups, we offer optional enhancements like color coding, machine readable data carriers, and laser marking, helping easy distinction between assays and alignment with your internal traceability practices.
5. Stability and secure delivery
IVDR indicates that reagents must remain safe and functional throughout their lifecycle. In line with this, we conducted stability studies on premixed formulations (i.e. primers and probes and/or master mixes). As a result, we are able to assign a validated expiry date and recommended storage temperature to your premixed assay, ensuring reagent performance and safety for the entire duration of use. Assigning a single expiry date for the complete assay also simplifies stock and lot management on your side and reduces the risk of errors due to mismatched expiration dates across multiple raw materials, a key consideration for IVDR compliance. Once prepared, your premixed assay is shipped under tracked conditions, with temperature-controlled transport if needed to check integrity in transit. Partial deliveries from the same batch can also be arranged, offering storage under appropriate conditions and supply flexibility.
Conclusion
As IVDR enforcement approaches, clinical laboratories across Europe must adapt their in-house assay workflows to meet evolving regulatory expectations. Ensuring compliance now demands greater attention to manufacturing reliability, traceability, and documentation, especially when applying for exemptions. By partnering with Eurogentec for assay preparation, you benefit from a trusted manufacturing partner who delivers the documentation, batch control, traceability, and quality assurance essential for IVDR compliance. So you can stay focused on diagnostics while keeping full control over your assay design.
Ready to outsource your LDT preparation ?
Keep your design. Save time. Reduce risk. Stay compliant.
