The In Vitro Diagnostic Regulation, Regulation (EU) 2017/746, replaced the old In Vitro Diagnostic Directive and has applied since 26 May 2022. It governs every IVD placed on the EU market, from lab analysers to self-tests and companion diagnostics. Its framework mirrors the MDR roughly 80 percent, with the two big differences being classification and clinical evidence.

By Tibor Zechmeister and Felix Lenhard.

TL;DR

  • The IVDR is Regulation (EU) 2017/746. It replaced Directive 98/79/EC (the IVDD) and has applied since 26 May 2022.
  • An in vitro diagnostic medical device is a device intended to examine specimens derived from the human body, such as blood, urine, saliva, or tissue, to provide information about a physiological or pathological state.
  • The IVDR framework overlaps with MDR by roughly 80 percent. Quality management, manufacturer obligations, technical documentation structure, post-market surveillance, and notified body procedures follow the same logic.
  • Classification shifted from a list-based system with mostly self-declaration under the IVDD to a four-class risk-based system (A, B, C, D) that forces most modern IVDs into notified body review.
  • Clinical evaluation becomes performance evaluation: instead of trials on living subjects, manufacturers demonstrate scientific validity, analytical performance, and clinical performance using specimens.
  • The IVD notified body pool is smaller than the MDR pool, so choosing and engaging a body early is a survival move, not a formality.

Why this matters (Hook)

Tibor has watched more than one diagnostics founder discover, six months into development, that their self-certification plan no longer works. Under the old IVDD, the majority of IVDs could be placed on the market under the manufacturer's own declaration of conformity. Under the IVDR, that option collapsed for most devices. The regulation reclassified the space around risk, and the notified body suddenly appeared in the room.

For a startup, the shift is not academic. It changes runway, cost, team composition, and timing. A founder who has been building a PCR assay or a rapid antigen test or a clinical decision support tool connected to a lab analyser needs to know what framework applies before the first real investment in regulatory work. The IVDR is that framework. It has been in force long enough that ignorance is no longer a defense, and it is the single source of truth for every in vitro diagnostic question on the EU market.

Felix has coached dozens of founders through the "which regulation applies to us" conversation. The pattern is consistent. Teams want a quick answer, then a checklist, then a path. The IVDR supports that sequence, but only once the founder internalises that the regulation is the map and everything else (standards, guidance, consultancy) is commentary on the map.

What the regulation actually says (Surface)

Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices (the IVDR) was published in the Official Journal on 5 May 2017. It repealed Directive 98/79/EC. The date of application was 26 May 2022.

The regulation defines an in vitro diagnostic medical device as any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, piece of equipment, software, or system, intended by the manufacturer to be used in vitro for the examination of specimens derived from the human body, to provide information on physiological or pathological states, congenital abnormalities, predisposition to a medical condition, compatibility with potential recipients, monitoring of therapeutic measures, or similar purposes.

Structurally, the regulation follows the same logic as Regulation (EU) 2017/745 (the MDR):

  • Chapter I covers scope and definitions.
  • Chapter II covers the making available of devices, obligations of economic operators, including the manufacturer, and CE marking.
  • Chapter III covers identification and traceability, registration, Eudamed, and the summary of safety and performance.
  • Chapter IV covers notified bodies.
  • Chapter V covers classification and conformity assessment.
  • Chapter VI covers clinical evidence, performance evaluation, and performance studies.
  • Chapter VII covers post-market surveillance, vigilance, and market surveillance.

The annexes mirror the MDR's structure. There is a general safety and performance requirements annex (the IVDR equivalent of MDR Annex I), a technical documentation annex, conformity assessment route annexes, a classification annex, and a performance evaluation annex.

In Tibor's reading, the practical consequence is this. If a founder already understands MDR structurally, they can navigate IVDR with an 80 percent head start. The remaining 20 percent is where the two big differences live: classification logic and the concept of performance (rather than clinical) evaluation.

A worked example (Test)

Consider a Berlin-based startup building a smartphone-linked rapid lateral-flow test that identifies a specific bacterial infection from a saliva sample. The hardware is a strip cassette. The software is a mobile app that reads the cassette, grades the result, and stores it for the user.

Under the old IVDD, a device like this would, in many cases, have been self-declared by the manufacturer under Annex II or general IVDs. The clinical evidence bar was low. The notified body was rarely involved.

Under the IVDR, that changes on every axis. The device is an IVD, so IVDR applies. Classification is risk-based and depends on what is being detected, the medical decision the result informs, and whether it is used as a self-test. A test for a transmissible agent is likely in the higher classes, and self-tests generally move up. That, in turn, triggers notified body involvement and a formal performance evaluation built on scientific validity, analytical performance, and clinical performance data.

Now apply the Subtract to Ship lens. The founder's first instinct is often to treat the test as a consumer product with a medical wrapper. That is the expensive mistake. Felix has seen it end in eight-figure losses across the MedTech coaching portfolio. The correct first move is to read the IVDR, write down the intended purpose in plain language, check the classification rules against that intended purpose, and only then start sizing the regulatory path. This is two weeks of work, not two quarters. It is also the difference between a viable startup and a pivot.

The Subtract to Ship playbook (Ship)

In Tibor's experience, the diagnostics founders who survive the IVDR transition did a handful of things early. Felix has turned those moves into a repeatable playbook.

  1. Confirm the regulation applies. Write the intended purpose of the device in one paragraph. If any part of it involves examining specimens derived from the human body to provide information on a physiological or pathological state, the IVDR applies. Do this on paper before speaking to a single consultant.
  2. Classify the device. Use the IVDR classification rules to place the device in Class A, B, C, or D. Document the reasoning. A classification justification is not optional under the IVDR, and it will be reviewed by the notified body.
  3. Map the conformity assessment route. The classification drives the route. Class A (non-sterile) is the only self-declared tier in practice. Everything else involves a notified body in some form. Knowing the route before committing to the technical build protects runway.
  4. Stand up a compliant QMS. The IVDR requires a quality management system aligned with the same general logic as MDR Article 10. In practice, this means EN ISO 13485:2016+A11:2021 with IVDR-specific interpretation.
  5. Plan the performance evaluation. Scientific validity, analytical performance, and clinical performance are the three pillars. Think of this as the IVDR equivalent of the MDR clinical evaluation report, framed around specimens rather than subjects.
  6. Engage a notified body early. The IVD notified body pool is small, as Tibor has pointed out in every follow-up interview on this topic. Founders who wait are founders who lose months.
  7. Design for post-market from day one. Post-market surveillance and vigilance obligations under the IVDR are not lighter than under the MDR. Subtract complexity up front by building the data infrastructure now.

Subtract everything that is not on this list during the first ninety days. The founder's job is to make the path as narrow and clean as possible, not to build scope before the framework is understood.

Reality Check

Answer honestly. Each "no" is a subtraction opportunity.

  1. Has the team written down the device's intended purpose in plain language, no more than one paragraph?
  2. Can the team state, with reference to IVDR classification rules, which class the device falls into?
  3. Is the team confident the device is an IVD and not a medical device under the MDR, or a borderline product?
  4. Does the team understand that self-declaration is no longer the default route for most IVDs?
  5. Has the team started identifying notified bodies with active IVDR designation in its device category?
  6. Has the team scoped what scientific validity, analytical performance, and clinical performance mean for this specific device?
  7. Is there a QMS roadmap aligned with EN ISO 13485:2016+A11:2021 and the IVDR?
  8. Does the team know the cost range of an IVDR certification for its class, and has it budgeted accordingly?

Fewer than six yes answers means the team needs to stop building features and start reading regulation.

Frequently Asked Questions

Is the IVDR the same as the MDR? No. The MDR is Regulation (EU) 2017/745 and governs medical devices. The IVDR is Regulation (EU) 2017/746 and governs in vitro diagnostics. They are twin regulations published on the same day, sharing structure and philosophy, but with different scopes.

When did the IVDR start to apply? The IVDR became applicable on 26 May 2022, replacing Directive 98/79/EC.

Is our software an IVD or a medical device? If the software examines specimens derived from the human body to provide diagnostic information, it is an IVD and IVDR applies. If the software provides medical information without analysing specimens, it is a medical device and MDR applies. The intended purpose statement determines the answer.

Do we still need a notified body if we only sell in one EU country? Yes. The EU single market is one regulatory space. Selling in any member state means complying with IVDR for the whole EU. A notified body is required for most classes regardless of which member state is the commercial target.

Can we use our MDR QMS for IVDR? Partially. The QMS core based on EN ISO 13485:2016+A11:2021 is shared. Several processes, in particular performance evaluation and post-market performance follow-up, need IVDR-specific adaptation.

What happens to CE certificates issued under the old IVDD? Transitional provisions allow continued placing on the market for certain legacy devices under conditions. Consult the current consolidated text of the IVDR and any amendments before relying on a legacy certificate.

Sources

  1. Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices. OJ L 117, 5.5.2017.
  2. Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, consolidated text, Article 10.
  3. EN ISO 13485:2016+A11:2021, Medical devices, Quality management systems, Requirements for regulatory purposes.
  4. EN ISO 14971:2019+A11:2021, Medical devices, Application of risk management to medical devices.