The IVDR transition: new duties for in-vitro diagnostic devices

A diagnostics company that has sold the same immunoassay across Europe for fifteen years opens a letter from its distributor: the hospital will not renew unless the product carries a certificate issued by a notified body. The manufacturer has never worked with one. Under the directive that governed in-vitro diagnostics until recently, this assay was self-declared, signed off in-house, and placed on the market without any third party reading the file. Under the In Vitro Diagnostic Regulation, the same product is Class C, and a notified body now stands between it and every European customer. Nothing about the test changed. The rules around it did.

This is the heart of the IVDR transition, and it is catching companies that did everything right under the old regime. Regulation (EU) 2017/746, the in-vitro counterpart of the Medical Device Regulation, replaced the In Vitro Diagnostic Directive on 26 May 2022, and it did not simply tighten the existing framework. It rebuilt how an IVD is classified, who has to assess it, and what evidence has to sit behind it. For laboratory-diagnostics makers, the work is less about learning a new certificate and more about discovering that a product they considered settled has moved into a category with far heavier duties.

From a fixed list to a risk grid

The directive classified in-vitro diagnostics with a list. A short Annex II named the higher-risk products, List A and List B, plus self-tests, and everything not on those lists, the large majority, was self-certified by the manufacturer alone. If your assay was not named, it carried the lightest possible route to market.

The Regulation sets that list aside and replaces it with a rule-based grid. Annex VIII lays out seven classification rules that sort every device into one of four classes, from Class A at the lowest risk to Class D at the highest, weighing the risk to the individual patient against the risk to public health. A test that detects a transmissible agent in blood destined for transfusion sits at Class D. A companion diagnostic or an infectious-disease assay typically lands at Class C. General laboratory reagents and instruments tend toward Class A. Because classification now follows what a test does and how its result is used, rather than whether a committee once wrote it onto a list, products that were invisible under the directive suddenly carry a class, and with it a conformity route. How each class maps to an assessment path is set out on our in-vitro diagnostic devices page; the shift to grasp first is who now has to be in the room.

Why almost every manufacturer now meets a notified body

Under the directive, only the Annex II minority needed a notified body. The Regulation inverts that picture. Class A devices that are not sterile stay self-declared, but Classes B, C and D all require notified-body involvement, and most in-vitro diagnostics fall into those three classes. The practical result is a reversal: a field where the great majority of products reached the market on the manufacturer's own declaration now sends the great majority through third-party assessment.

That reversal collides with capacity. The number of notified bodies designated under the IVDR is small relative to the volume of devices that suddenly need them, and designation itself is slow. A manufacturer cannot treat the certificate as a formality booked a few weeks ahead. The queue is real, the document review is deeper than anything the directive asked for, and a Class D device also faces extra layers: a European Union reference laboratory verifies performance, and common specifications set mandatory requirements that the notified body checks against. Booking a notified body early, before the file is even complete, has become one of the few levers a company genuinely controls.

The staggered transition, class by class

Recognising that the notified-body system could not absorb every device at once, the legislator built a staggered runway rather than a single cut-off. The original date of application in May 2022 stood, but Regulation (EU) 2022/112 introduced transitional periods that let compliant devices already on the market keep selling while their makers worked through assessment. Regulation (EU) 2024/1860 then extended those periods again and tied them to the device's risk class, so that the highest-risk products move first.

For devices that held a valid certificate or declaration under the directive, the later dates run by class: highest-risk Class D devices may rely on the transitional arrangement until the end of 2027, Class C until the end of 2028, and Class B together with sterile Class A until the end of 2029. None of this is automatic. The extension holds only while the device stays compliant, while its design and intended purpose do not change in any significant way, and while the manufacturer keeps a quality management system in place and has lodged a formal application with a notified body before the deadlines the Regulation sets. Miss the application window and the runway disappears, whatever the headline date says.

The danger in the staggered dates is that they read like breathing room and function like a deadline. The assessment work that has to finish before the date, building the technical documentation, completing performance evaluation, and securing a slot with a notified body, takes far longer than the calendar suggests when it is read from the wrong end.

A higher bar for evidence

The Regulation also redefines what proof a manufacturer has to hold. The directive's lighter expectations give way to a structured performance evaluation built on three pillars: scientific validity, which establishes that the analyte is linked to the clinical condition; analytical performance, which shows the assay measures what it claims to measure; and clinical performance, which shows the result is meaningful in the intended clinical context. These come together in a performance evaluation report that has to be kept current, not filed once and forgotten.

For higher-risk devices the demands climb further. Class D products are checked against common specifications and verified by an EU reference laboratory. Across every class that needs a notified body, the technical documentation has to demonstrate, not assert, that the device performs and that the residual risks have been weighed against the clinical benefit through a disciplined risk management process. A file that would have passed under the directive will not survive this reading, because the questions being asked are different in kind, not only in depth.

Duties that outlast the certificate

Some of the heaviest new obligations are not the certificate at all; they are the system that has to surround it. Every manufacturer must designate a person responsible for regulatory compliance, an Article 15 role that cannot be an empty title. Devices and their makers have to be registered in EUDAMED, and each device carries a unique device identification that follows it through the supply chain. Once a product is on the market, post-market performance follow-up has to keep gathering evidence that the device still performs as claimed, feeding a vigilance system that reacts to incidents.

Underneath all of it sits the quality management system. The Regulation expects a manufacturer to run one, and in practice that means an ISO 13485 quality management system shaped to the requirements of the IVDR. The certificate proves the device at a moment in time; the quality system is what keeps that proof honest as reagents are reformulated, software is updated, and suppliers change. Treating the two as one continuous obligation, rather than a hurdle followed by a filing cabinet, is what separates a clean surveillance audit from a scramble.

In-house tests are no longer outside the frame

One group long accustomed to working outside the directive now finds itself addressed directly: health institutions that make and use their own tests. The Regulation's Article 5(5) sets conditions under which a laboratory may manufacture and use an in-house device without taking it through the full conformity route, but those conditions are real. The institution has to operate an appropriate quality management system, justify why an equivalent device on the market does not meet the need, and document the device's performance. Accredited laboratories that already work to ISO 15189 start from a stronger position, because much of the quality and competence evidence the exemption asks for is already part of how they run. The lesson for hospital and reference laboratories is that the exemption is a set of duties, not a way around them.

Reading the time that is left

The companies handling the IVDR transition well are the ones that stopped treating it as a paperwork refresh and started treating it as a reclassification of their own portfolio. The first move is honest classification: run every product through the Annex VIII rules and see which ones gained a class, and a notified body, they did not need before. The second is to map each device against its transition deadline and the application window that really governs it. The third is to book notified-body capacity early, because that queue, not the published date, is the true constraint.

Read this way, the IVDR is less a wall than a sequence with a known order: classify, assemble the performance evidence, secure assessment, and keep the quality system running behind it. The deadlines reward the manufacturers who start from the back of that sequence and work forward in time, and they punish the ones who read the calendar from the front.