The IVDR (Regulation (EU) 2017/746) and the MDR (Regulation (EU) 2017/745) share roughly 80 percent of their framework. Quality management, manufacturer obligations, technical documentation, post-market surveillance, and notified body procedures are nearly identical. The two big differences are classification (the IVDR uses a four-class system with far fewer rules) and evidence (the IVDR requires performance evaluation rather than clinical evaluation).

By Tibor Zechmeister and Felix Lenhard.

TL;DR

  • The MDR and the IVDR were published on the same day (5 April 2017) and share a common regulatory philosophy.
  • Roughly 80 percent of the two frameworks overlap, including QMS, Article 10-style manufacturer obligations, technical documentation structure, PMS, and vigilance.
  • The first major divergence is classification. The MDR has 22 classification rules in Annex VIII. The IVDR uses a smaller rule set and a four-class system (A, B, C, D) driven by the diagnostic target and the substances involved.
  • The second major divergence is the evidence regime. The MDR requires clinical evaluation on living subjects. The IVDR requires performance evaluation built on scientific validity, analytical performance, and clinical performance using specimens.
  • The IVD notified body pool is noticeably smaller than the MDR pool, which is a capacity risk startups must plan for.
  • Founders building hybrid products (a diagnostic device plus a medical device) may face both regulations simultaneously and need to scope each path separately.

Why this matters (Hook)

Tibor regularly meets founders who build a device that does both: it diagnoses (IVD territory) and it delivers a therapy or decision (medical device territory). The founder asks, "Which regulation applies to us?" The honest answer is often "both, but for different parts of your device." That conversation goes nowhere unless everyone in the room understands what the IVDR and the MDR share and where they diverge.

Felix has watched the same confusion play out in pitch decks and board meetings. Investors often treat "MedTech regulation" as a single topic. Founders who can calmly explain that their blood-analysing cartridge sits in IVDR Class C while the companion dosing pump sits in MDR Class IIb look senior on the topic, which matters for both funding and vendor negotiations.

The practical stakes are time and money. Two regulations mean two technical files, two sets of post-market obligations, and potentially two notified body engagements. Getting the split right at the planning stage saves quarters of runway later.

What the regulations actually say (Surface)

Regulation (EU) 2017/745 (the MDR) and Regulation (EU) 2017/746 (the IVDR) are twin regulations adopted on 5 April 2017. They replaced, respectively, the Medical Devices Directive (93/42/EEC) and the Active Implantable Medical Devices Directive (90/385/EEC) for the MDR, and the In Vitro Diagnostic Medical Devices Directive (98/79/EC) for the IVDR. The MDR applied from 26 May 2021. The IVDR applied from 26 May 2022.

Both regulations share a common skeleton:

  • General obligations for manufacturers, authorised representatives, importers, and distributors, anchored in the MDR around Article 10.
  • A requirement to establish and maintain a quality management system aligned with EN ISO 13485:2016+A11:2021.
  • Risk-based classification that determines the conformity assessment route.
  • Technical documentation requirements structured around general safety and performance requirements, design and manufacturing information, risk management, and evidence.
  • Post-market surveillance obligations with plans, reports, and periodic updates proportional to class.
  • Vigilance reporting for serious incidents and field safety corrective actions.
  • Notified body involvement for all but the lowest-risk classes.
  • Eudamed registration and unique device identification.

Tibor's summary of the overlap in his second follow-up interview was blunt. "Roughly 80 percent framework overlap. Intended purpose, classification, conformity assessment, technical documentation, notified body submissions, post-market surveillance, quality management. Two major differences: classification, and the shift from clinical evaluation to performance evaluation."

The remaining 20 percent is where the two regulations part ways.

Where they diverge: classification

The MDR contains 22 classification rules in Annex VIII, covering non-invasive devices, invasive devices, active devices, and special rules including software (Rule 11). MDR classes are I, IIa, IIb, and III.

The IVDR uses a different logic. Classification rules are fewer. Classes are A, B, C, and D, where Class A is the lowest risk and Class D is the highest. Class D covers devices intended to detect the presence of transmissible agents in blood, blood components, cells, tissues, or organs.

In Tibor's framing, the key shift is conceptual. MDR classification asks how invasive the device is, how long it stays in contact with the body, and how much energy it delivers. IVDR classification asks what you are diagnosing and what substances you are working with. The diagnostic target and the specimen type drive the decision. A founder who tries to intuit IVDR classification from MDR instincts will get it wrong.

A further practical point: under the IVDD (the old directive), most IVDs could be self-declared by the manufacturer. Under the IVDR, notified body involvement is required for most classes, which was a step-change for the industry and one of the main reasons the transition was contentious.

Where they diverge: evidence

Under the MDR, manufacturers must perform a clinical evaluation and produce a Clinical Evaluation Report under Article 61 and Annex XIV. Clinical evaluation involves collecting, appraising, and analysing clinical data from the device and, where justified, equivalent devices. When existing data is insufficient, a clinical investigation under Articles 62 to 82 and Annex XV is required. Clinical investigations involve living subjects.

Under the IVDR, the equivalent discipline is called performance evaluation. The evidence is built on three pillars:

  1. Scientific validity, the association of an analyte with a clinical condition or physiological state.
  2. Analytical performance, the ability of the device to detect or measure the analyte correctly.
  3. Clinical performance, the ability of the device to yield results that correlate with the clinical condition.

Performance studies under the IVDR typically use specimens (blood, saliva, tissue, urine) rather than live subjects in a clinical investigation sense. Tibor's one-line summary: "No live human subjects. Instead, blood, saliva, tissue samples used to prove diagnostic accuracy or identification rate."

This is not a minor relabeling. It changes study design, ethics committee involvement, statistical planning, and budget. A founder who mentally maps "clinical evaluation equals performance evaluation" and stops there will under-scope the work.

Where they diverge: notified body capacity

The IVD notified body pool is smaller than the MDR pool. Tibor's blunt observation: "Finding a notified body is harder." For a startup, that translates into longer waiting lists, fewer options if a relationship fails, and less negotiating room on fees and timelines. Felix's Subtract to Ship advice on this is consistent: lock in a notified body relationship earlier than instinct suggests.

A worked example (Test)

Consider a team building a companion diagnostic. The product has two halves:

  • Half A: a molecular assay kit that detects a specific biomarker in a tumour biopsy, used to decide whether a patient should receive a particular oncology drug.
  • Half B: a benchtop analyser that runs the assay, reads the fluorescence signal, and outputs the result.

The assay kit is an in vitro diagnostic device under the IVDR. The analyser, as the instrument used to perform the examination, is also within IVDR scope. Because this is a companion diagnostic informing a specific therapeutic decision, the classification is likely high under the IVDR (Class C in many companion diagnostic cases, with consultation obligations).

Now consider a variant. The same team adds a connected insulin pump that administers a dose based on a lab analyser result. The pump is a medical device under the MDR. That moves it into a separate regulatory track with its own classification, its own notified body engagement, its own technical documentation, and its own clinical evaluation under MDR Article 61.

Felix has coached teams in exactly this situation. The right move is rarely to try to merge the regulatory work. The right move is to separate the two tracks at the planning stage, budget each independently, and look for operational efficiencies (shared QMS, shared PMS infrastructure, shared risk management backbone) rather than trying to collapse two distinct regulatory paths into one.

The Subtract to Ship playbook (Ship)

  1. Decide, on paper, which regulation applies to which part of your product. If the answer is "both," write two separate regulatory plans.
  2. Map the common 80 percent once. The QMS, risk management, technical documentation skeleton, PMS infrastructure, and manufacturer obligations can serve both tracks with minor adjustments.
  3. Scope the diverging 20 percent twice. Classification and evidence strategy must be done independently for each regulation.
  4. Engage notified bodies in the right order. IVD notified body capacity is tighter, so start that outreach first if both regulations apply.
  5. Budget realistically. Two tracks often cost 1.5x to 1.7x a single track, not 2x, because of infrastructure reuse. The premium is real but the savings are also real.
  6. Separate your documentation from day one. Technical files for an IVD and a medical device are not interchangeable. Trying to maintain one merged file is a source of audit findings.

Felix's Subtract to Ship rule applies here too: the founder's job is to narrow, not to expand. Two regulations look like double the work, and they are more work, but clean separation subtracts confusion and downstream rework.

Reality Check

  1. Can the team state, with one sentence each, whether each component of its product is an IVD, a medical device, or both?
  2. Has the team located the IVDR classification rules that apply to the diagnostic components?
  3. Has the team located the MDR classification rules (Annex VIII) that apply to any non-diagnostic components?
  4. Does the team understand the difference between clinical evaluation and performance evaluation as different evidence regimes, not as synonyms?
  5. Has the team mapped which notified bodies are designated for the relevant IVDR classes and device categories?
  6. Is the team's QMS plan structured to serve both regulations without duplicating work?
  7. Has the team budgeted PMS infrastructure for both regulations simultaneously?
  8. Does the team know which processes can be shared between the two tracks and which cannot?

Frequently Asked Questions

Can a single device be subject to both the IVDR and the MDR? Not the same physical device, but a single product system can contain parts under each regulation. A diagnostic assay plus a therapy delivery device is a common example. Each component follows its own regulation.

Does the MDR classification of software (Rule 11) have an IVDR equivalent? The IVDR classifies software based on the information it provides and the decisions that information drives, in line with the general IVDR classification logic. It is not a direct copy of MDR Rule 11.

Is performance evaluation cheaper than clinical evaluation? Not necessarily. The structure is different, but high-class IVDs can require substantial specimen panels, comparator studies, and statistical analysis. The cost depends on the evidence gap, not the label on the process.

If we have an MDR-certified QMS, how much extra work is IVDR certification? The core EN ISO 13485:2016+A11:2021 QMS transfers. Performance evaluation processes, IVDR-specific classification rationale, and IVDR-aligned post-market performance follow-up need to be added.

Can we use the same notified body for both MDR and IVDR? Only if that body is designated under both regulations and for the relevant device categories. Many bodies are designated under one and not the other. Check the NANDO database before assuming.

Which regulation came first in practice for startups? Both apply now. The MDR has been applicable since 26 May 2021 and the IVDR since 26 May 2022. Neither is optional.

Sources

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