IVDR in 2026: What Manufacturers Have Learned So Far

Since it became applicable in May 2022, manufacturers have had to raise their game on classification, performance evaluation, clinical evidence, technical documentation, post-market surveillance and conformity assessment. Four years in, the industry has enough practical experience to see clearly where the real difficulties lie — and what those difficulties teach us about how to develop the next product.

The central lesson is blunt: compliance is not a matter of updating technical files. For most organisations it means changing how products are developed, how quality systems operate, how responsibilities are assigned, and how regulatory requirements are handled across the whole product lifecycle.

Here is what the first four years have taught us.

Compliance is not a matter of updating technical files

Regulatory strategy has to start with the product, not follow it

The clearest lesson is that regulatory strategy cannot be left until the end of development.

Under the old Directive, a manufacturer could often carry a product a long way down the development path before confronting the full weight of the regulatory requirements. IVDR closes that door. Intended purpose, classification, performance evaluation, clinical evidence and conformity assessment all shape the development strategy itself, and they interact.

The clearest illustration is the intended purpose. It drives classification, which drives the level of evidence and the conformity assessment route. Change the intended purpose late — narrow the target population, add a clinical claim, tie the result to a treatment decision — and you can move the device into a higher class, pull in a notified body that was not previously required, and, for a companion diagnostic, trigger a mandatory consultation with a medicines authority. A wording change that looks editorial can reset the timeline by a year or more.

So regulatory strategy belongs alongside the product development strategy from day one. On any new product, regulatory, quality, clinical and R&D should be aligned from the first design review — not introduced when the technical file is being assembled.

Classification is now a strategic decision

IVDR replaced the old list-based approach with a rules-based system that sorts IVDs into Classes A, B, C and D by intended purpose, risk and the consequences of a wrong result. Classification is no longer an administrative step. It sets the conformity assessment route, whether a notified body is involved at all, the depth of performance evaluation, the clinical evidence expected, the timeline, the cost of compliance and the post-market obligations.

The scale of the shift is easy to state. Under the old Directive, roughly four in five IVDs were self-certified with no notified body involvement. Under IVDR that position has almost exactly reversed: around four in five now require a notified body. Companion diagnostics are the sharpest example — self-certified for many manufacturers under the Directive, they are Class C under IVDR (Rule 3 of Annex VIII), requiring third-party conformity assessment and a scientific consultation on the drug–test linkage that did not exist before.

Because classification now determines so much, its consequences have to be understood before a decision becomes embedded in the programme. A small change to intended use, target population or clinical application can move the whole regulatory pathway — and by the time it is discovered in the technical documentation, the cost of unwinding it is high.

Performance evaluation is a development activity, not a document

The increased weight given to performance evaluation has been one of the biggest practical adjustments.

Manufacturers have always been comfortable with analytical performance — accuracy, precision, analytical sensitivity and specificity, measuring range, interference, cross-reactivity and detection capability. IVDR asks for something wider. Performance evaluation has to bring scientific validity, analytical performance and clinical performance together into a single, coherent body of evidence that demonstrates the device performs as intended and supports its clinical purpose.

The recurring failure is to treat those three strands as separate exercises. A strong analytical validation package does not, on its own, establish clinical performance. A technically impressive assay can still lack the evidence that it is clinically meaningful for the population and purpose claimed. When the strands are generated independently and stitched together at the end, the gaps show up under notified body review — at the worst possible moment.

Performance evaluation has to be planned and built as part of development, with the evidence streams designed to support each other from the outset.

Evidence gaps have to be found early, because finding them late is expensive

IVDR has changed how manufacturers think about evidence. Historically, a manufacturer might have leaned on published literature, legacy data or established market experience. IVDR expects a documented evidence strategy matched to the specific device and its intended purpose.

That forces a set of practical questions early: what evidence already exists, what can realistically be generated, where the gaps are, how much clinical performance data the intended purpose actually demands, whether existing literature genuinely applies to this device, what role external laboratories or clinical sites will play, and how the evidence will be maintained across the lifecycle.

Companion diagnostics show why this matters. A CDx is often developed against a drug whose pivotal trials have already run — and the samples from those trials may no longer exist, or may not be accessible to the diagnostic manufacturer. A programme that assumed it could lean on that trial data can discover, well into development, that the clinical performance evidence has to be generated from scratch. Finding that out early is a planning problem. Finding it out late is a budget and time-to-market problem.

Notified body engagement is a programme in its own right

For any device needing a notified body, conformity assessment has become a major workstream — and the transition has made painfully clear why it has to be planned as one.

The market is capacity-constrained. Fewer than twenty notified bodies are designated under IVDR, against roughly fifty under MDR and around eighty in the old Directive era, and typical review cycles run to well over a year. That shortage is not a background detail; it is the reason the Commission extended the transition deadlines through Regulation (EU) 2024/1860, staggering the hard cut-offs to end-2027 for Class D, end-2028 for Class C, and end-2029 for Class B and sterile Class A, explicitly to avoid diagnostics disappearing from the market. Securing a slot — and a signed agreement within the required window — is itself a gating item.

Submission is rarely linear. Questions raised in review routinely generate new investigations, documentation updates or fresh evidence requirements, and the Commission’s 2026 implementing rules on how notified bodies conduct assessments have tightened expectations further. The underlying development work can be complete while the manufacturer is still not ready for conformity assessment, simply because the evidence has not been assembled into a coherent, reviewable package. Submission readiness — not just development completeness — is what the timeline turns on.

Outsourcing activity does not outsource accountability

Modern IVD development is rarely done by one organisation. A manufacturer may depend on contract assay developers, design houses, CROs, clinical laboratories, external test facilities, software developers, component suppliers and pharmaceutical partners.

IVDR does not dilute the manufacturer’s responsibility because work is contracted out. That makes the allocation of responsibility between manufacturer and partner a first-order design task. Across the full arc — requirements, design, verification, validation, performance evaluation, clinical evidence, regulatory submission and post-market surveillance — responsibilities, deliverables, review points and quality controls have to be explicit at every stage.

This is most acute for companion diagnostics and clinical trial assays, where a single programme can span a pharmaceutical sponsor, an assay developer, one or more laboratories and multiple clinical sites, with a medicines authority consulted on the drug–test linkage. When accountability is assumed rather than defined, the gaps sit precisely at the handoffs — and they surface in audit and review, not in the day-to-day work. Outsourcing the activity never outsources the accountability.

The quality system has to run the process, not just record it

Documentation alone does not deliver IVDR compliance. Manufacturers need quality systems that actively support the work of developing, manufacturing and maintaining compliant IVDs — design and development, risk management, supplier and external-provider control, performance evaluation, clinical evidence, change control, post-market surveillance, vigilance, CAPA, technical documentation and regulatory submissions.

The difficulty is rarely a missing procedure. It is the interfaces between them. A design control SOP, a performance evaluation SOP and a supplier management SOP can each be sound in isolation and still leave gaps where they meet — the point where a supplier’s validation data has to feed the performance evaluation, or where a design change has to reopen the clinical evidence. IVDR rewards looking at the end-to-end process, not the individual SOP.

Post-market surveillance is part of the product, designed in from the start

Under IVDR the regulatory journey does not end at CE marking. Manufacturers have to keep gathering and evaluating information on the performance and safety of their devices — complaints, incidents, literature, customer feedback, performance data, field experience, trend signals and scientific developments.

The objective is not a periodic report for its own sake. Post-market information has to feed back into risk management, performance evaluation and product decisions, creating a continuous loop between real-world experience and development. That only works if PMS is designed alongside the product, rather than bolted on after launch.

What this actually means for IVD manufacturers

The biggest lesson of the first four years is that IVDR is not, at heart, a demand for more documentation. It is a demand for a more integrated product lifecycle.

Product strategy, regulatory strategy, the quality system, risk management, design and development, performance evaluation, clinical evidence, conformity assessment and post-market surveillance are not a sequence of independent stages. Run them separately and you get gaps and duplication. Connect them and regulatory requirements become part of how the product is developed, rather than a layer applied on top of it.

Beyond 2026

The landscape is still moving. Guidance keeps developing, notified bodies keep refining their expectations, the Commission has issued new rules on how conformity assessment is conducted, and the European framework itself is under review. Compliance is not a one-off transition exercise to be completed and filed.

The questions worth asking regularly are straightforward:

• Are our products correctly classified — and would they survive scrutiny if the intended purpose were tested?

• Is our evidence strategy strong enough for the intended purpose, not just the technology?

• Are our development and quality processes aligned with current requirements, at the interfaces as well as within each function?

• Do we have real oversight of our external development partners, with accountability defined rather than assumed?

• Can our PMS system produce meaningful information about real-world performance?

• Are regulatory considerations embedded early enough in new product development?

For manufacturers developing new IVDs, the takeaway is that regulatory requirements should shape product strategy from the outset. For those managing legacy portfolios, the focus is shifting from achieving compliance to making the systems, evidence and processes sustainable for the rest of each product’s life.

IVDR is not simply a new rulebook. It is a change in how IVD products are developed, evidenced, assessed and maintained across their entire lifecycle — and the organisations that treat it that way are the ones finding the transition manageable.