For IVD manufacturers: We build your performance evaluation under IVDR across its three pillars – scientific validity, analytical performance and clinical performance – through to an audit-proof performance evaluation file. The foundation is a robust state of the art, from which we derive your product-specific strategy, and hundreds of completed projects.
Robust state of the art
Three pillars evidenced
Notified Body ready
The IVDR requires evidence across three pillars. We build all three robustly – on the basis of a solid state of the art.
The analyte is demonstrably linked to the clinical or physiological state – evidenced through the state of the art and literature.
Your IVD correctly and reliably detects or measures the analyte – demonstrated through the applicable analytical performance characteristics.
The test results correlate with the targeted clinical state – evidenced through clinical performance studies.
The IVDR sets out clear requirements for performance evaluation in Annex XIII – complemented by the MDCG guidance. What remains demanding is the product-specific interpretation and the performance evaluation strategy: it is rarely black and white – there is always room for interpretation. This is exactly where we come in – with a robust state of the art and a solid scientific validity as the basis for an objectively justified strategy with a sound chain of argument. If the file is incomplete, the Notified Body often does not even begin the review of the technical documentation.
Queries and rework from the Notified Body drag out your conformity assessment procedure.
A performance study without a valid design or sample-size planning may have to be repeated – and paid for twice.
As long as your IVD is not on the market, your competitors earn – not you.
If you submit an incomplete performance evaluation, the Notified Body often does not even take up the review of the technical documentation.
Against these costs, a performance evaluation built robustly from the outset is a calculable investment – based on a robust state of the art and an objectively justified strategy.
What if experts built your performance evaluation from the outset the way the IVDR (Annex XIII) and your Notified Body measure it – across all three pillars, instead of defending it against queries afterwards?
Experts who develop a robust state of the art and the scientific validity and build on it a product-specific strategy with objective justification and a clear line of reasoning – with hundreds of completed projects and a 99.9% success rate?
That is exactly what our service for the performance evaluation of IVDs under IVDR is for.
A clear, predictable process – aligned with the logic of the IVDR (Annex XIII) and the review practice of the Notified Bodies.
We gain an overview of your IVD, your data and documentation and compare them – partly on a sampling basis – against the IVDR and the state of the art.
We produce or review the state-of-the-art report as the strategic basis and develop from it your Performance Evaluation Plan (PEP) incl. a product-specific strategy with objective justification.
We support the planning and reporting of analytical and clinical performance (including per CLSI) – conducting the studies is up to you. Finally, we consolidate everything in the Performance Evaluation Report (PER).
We ensure completeness for the Notified Body review and keep your file continuously up to date via PMS and, if applicable, PMPF – given appropriate input and a data basis from your side.
Comprehensive support for your IVD performance evaluation – from the state of the art through the strategy to a submission-ready file:
We research and document the state of the art – medical/diagnostic and technological. It is the strategic basis that determines the effort for all further activities. We take on the systematic literature search and the report.
Your benefit: A robust foundation for your entire performance evaluation strategy.
We support the systematic literature search and the report evidencing scientific validity – or review your existing report for compliance.
Your benefit: The link between analyte and clinical condition – cleanly evidenced.
Based on the state of the art and scientific validity, we develop your product-specific strategy – with objective justification, a clear line of reasoning and a realistic weighing of effort and feasibility.
Your benefit: A viable strategy before study budgets are committed.
You provide the evidence for the applicable analytical performance parameters through studies. We help with the planning (including taking the CLSI requirements into account) and the reporting.
Your benefit: Studies that are validly planned and count the first time.
Depending on the state of the art and the strategy in the PEP, we support the planning of the clinical performance evidence – and broker a suitable CRO if needed.
Your benefit: The right route to the evidence – without unnecessary studies.
The PER summarizes all three pillars and demonstrates a positive benefit-risk ratio. We write, review and update it – submission-ready for the Notified Body.
Your benefit: Compliant, well-reasoned documents – that convince in audits and technical reviews.
From the PMPF plan through collecting and evaluating the post-market data to the PMPF report – we keep your performance evaluation file continuously up to date and compliant.
Your benefit: Your file stays audit-proof – across the entire lifecycle.
There are three routes for the performance evaluation – depending on how much you want to do yourself. This page is for the last one: having it created in full.
You learn the principles of performance evaluation – in general and through examples, not on your product.
You develop the performance evaluation strategy for one specific IVD – yourself, with our expert, on your documentation. Including first study concepts.
We create your performance evaluation – from the state of the art through the strategy to a submission-ready file.
Maximum benefit and maximum certainty – with minimal time and effort on your part.
An audit-proof performance evaluation file that meets the IVDR requirements.
Hundreds of completed projects, deep experience with Notified Bodies.
Performance evaluation in a short, predictable time – without surprises.
We deliver the research, strategy and reports – sign-off and responsibility stay with you.
We develop the state of the art and the scientific validity, derive from it a product-specific strategy with a clear, objective line of reasoning and document everything submission-ready. Sign-off and responsibility stay with you as the manufacturer – as the IVDR provides; we deliver the technically sound groundwork.
We tailor your individual quote to your product and data situation in the free introductory call.
A clearly calculated quote – a fraction of what months of delay or an incomplete performance evaluation cost.
We have completed hundreds of projects in IVD regulatory affairs. We develop the state of the art and the scientific validity and derive from it a product-specific strategy with a clear, objective line of reasoning – the basis for a file that withstands the Notified Body review. Sign-off and responsibility stay with you.
“The collaboration with the Johner Institut was thoroughly professional, efficient and pleasant. In preparing the state-of-the-art report and the scientific validity, as well as documenting the test plans for the analytical performance studies, we received competent and reliable support. The structured approach, the scientific expertise and the practical recommendations convinced us. Many thanks for the excellent collaboration!”
— Customer, name withheld on request
Have your performance evaluation built or revised by experts – based on a robust state of the art and an objectively justified strategy. Start with a no-obligation introductory call.
Book an Introductory Call →In the call our experts get to know your product and capture the status of your data and documentation. Within 48 hours afterwards you receive your individual quote – reviewed under our four-eyes principle. No obligation, no effort for your team.
Within 48 hours your quote is ready – reviewed under the four-eyes principle and transparently calculated based on scope.
For the creation of your performance evaluation based on the existing data we give you firm dates – instead of rough estimates. If evidence first has to be generated – such as a performance study – we clearly delimit that in the call.
We will get in touch shortly to schedule your introductory call.
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