We help you to systematically assess which requirements of Regulation (EU) 2017/746 are relevant to your organisation, identify areas for action, and plan the next steps in a realistic and structured manner.
We help you to document your IH-IVD in a transparent and consistent manner and to prepare effectively for audits and regulatory enquiries.
We support you with regulatory, quality and methodological issues – from in-house IVD dossiers, through performance evaluation and risk management, to the further development of your quality management system, as well as matters relating to software, AI and relevant interfaces with the AI Act.
Together, we develop solutions tailored to your procedures, products, processes and resources – with a direct focus on your laboratory practice.
Our team of experienced IVD experts covers all relevant areas, from risk management to performance evaluation. We keep track of all the key regulations and standards on your behalf and help you achieve compliance in all relevant areas.
You benefit not only from the expertise we share with you, but also from templates that have proven their worth time and time again in audits and reviews. This ensures you’re on the safe side, whilst also saving you time and money.
Healthcare organisations that manufacture and use their own in-vitro diagnostic medical devices must ensure that these in-house IVDs comply with the applicable requirements of Regulation (EU) 2017/746 on in-vitro diagnostic medical devices (IVDR). For many medical laboratories, this means systematically reviewing and refining existing procedures, documentation and processes.
In practice, this often raises similar questions: Which requirements are actually relevant to our organisation? Where are the gaps? How can documentation, performance evaluation, risk management and quality management be implemented with a reasonable level of effort?
Furthermore, these tasks usually have to be carried out alongside day-to-day operations. Limited staff and time resources make structured implementation even more challenging.
We support healthcare facilities and laboratories from the thorough assessment of IH-IVD requirements right through to their practical implementation – including the drafting and revision of documents, the organisation of relevant evidence and the development of tailor-made solutions.
Contact us now to plan your first steps towards IVDR compliance.
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Whether it’s an initial assessment, targeted optimisation or practical implementation: we support healthcare facilities and laboratories with tailored service modules to help them meet the requirements for in-house IVD safely, efficiently and in a practical manner. In doing so, you’ll not only receive expert guidance but, if required, hands-on support with drafting documents, structuring your evidence and further developing your processes.
With our support, you can ensure the quality of your analytical and clinical performance studies and their results.
We help you to pass the approval, audits, and technical reviews quickly and safely with legally compliant performance evaluation files.
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e-learning courses, seminars, and workshops are the key.
‘In-house IVD’ and ‘LDT’ are often used in similar contexts or even as synonyms. However, the terms are not automatically interchangeable. The key factor for regulatory classification as an in-house IVD is whether the specific assay meets the definition of an IVD under Article 2(2) of the IVDR, as well as the requirements for in-house manufacture under Article 5(5) of the IVDR. If these criteria are not met, it may still be an LDT, but not an in-house IVD.
Healthcare organisations must check for each in-house IVD whether it meets the requirements set out in Article 5(5) of the IVDR. These include, amongst other things, a suitable quality management system, compliance with the essential safety and performance requirements, and traceable documentation. A gap analysis shows where your organisation stands, which issues remain unresolved and which measures take priority.
The in-house IVD dossier compiles the relevant evidence for the specific procedure. This may include documentation on the intended purpose, manufacture, performance evaluation and risk management. Which documents are required – and, in particular, their scope – depends on the specific in-house IVD. A clearly structured file facilitates internal reviews and preparation for audits or enquiries from regulatory authorities.
The IVDR sets out the same requirements for in-house IVDs across Europe. ISO 15189 is also relevant for quality management and laboratory practice. The Rili-BÄK is mandatory only for laboratories based in Germany. The IVDR requires compliance with the state of the art and thus adherence to further regulations and guidelines. Check which requirements apply to your laboratory and what impact they have on your existing processes.
Software and AI can form part of an in-house IVD or support laboratory processes. The applicable requirements depend, amongst other things, on the intended purpose, function and technical characteristics. In addition to the IVDR, provisions of the AI Act may also be relevant for AI applications. The key factor is the classification of the specific application and its role in the procedure.
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