MDR vs IVDR: the essential differences to know

The MDR (EU 2017/745) and the IVDR (EU 2017/746) were published on the same day, 5 April 2017, and rest on a common architecture. Yet they apply to two families of products with very different logics — and confusing the two frameworks is one of the costliest mistakes a QA/RA team can make.

This guide sets out the essential distinctions, the overlap zones and the classic pitfalls.

Common architecture, distinct purposes

Before the differences, what the two regulations share:

• An almost identical structure of chapters and annexes
• The same principles: safety, performance, risk management, post-market surveillance
• The obligation for manufacturers to designate a PRRC (Article 15 in both texts)
• Mandatory registration in EUDAMED
• The Unique Device Identification (UDI) system
• CE marking as the outcome of conformity assessment

The divergences come from the very nature of the regulated products:

• The MDR governs medical devices that act directly on the patient: implants, instruments, equipment, therapeutic software, etc.
• The IVDR governs devices that analyze a sample taken from the patient (blood, urine, saliva, tissue) to provide information for diagnostic, prognostic or monitoring purposes.

This difference in purpose explains almost all the other divergences between the two texts.

Scope: what separates them

Covered by the MDR

• Medical devices in the classic sense (instruments, equipment, implants)
• Software as a medical device (SaMD) for therapeutic or planning purposes
• Devices without a medical purpose listed in Annex XVI
• Medical device accessories
• Custom-made devices

Covered by the IVDR

• Laboratory tests (clinical chemistry, haematology, microbiology, immunology, genetics)
• Self-testing and near-patient tests
• In vitro diagnostic software (interpretation algorithms, expert systems)
• Companion diagnostics — tests that guide a therapeutic decision for a medicinal product
• Tests intended to study inherited genetic diseases

The tricky overlap zone

A device that combines sampling and analysis may fall into either framework depending on its claimed purpose. Particular attention is needed for:

• Sterilisation devices (MDR)
• Laboratory information systems (LIS) which may be out of scope or IVDR depending on their functions
• Drug-device combination products additionally governed by Directive 2001/83/EC

Classification: two different logics

Under the MDR (Annex VIII)

Four risk classes (I, IIa, IIb, III) according to rules taking into account:

• Duration of use (transient, short term, long term)
• Invasive nature (non-invasive, invasive, implantable, active)
• Contact with the body (skin, wound, vital organs, circulatory system)

Under the IVDR (Annex VIII)

Four risk classes as well (A, B, C, D) based on two distinct criteria:

• The risk to the patient linked to an erroneous result
• The risk to public health linked to the spread of a disease or a false alert

IVDR class	Risk	Examples
A	Low	General reagents, culture media, general instruments
B	Moderate	Pregnancy tests, cholesterol tests, glycated haemoglobin
C	High	Cancer tests, cardiac markers, common serologies
D	Very high	HIV tests, hepatitis, prenatal screening, blood donors

Major change compared with the former Directive 98/79/EC: previously, around 80% of IVDs were self-declared without a notified body. Under the IVDR, more than 80% require notified body assessment. The need for certification capacity exploded, creating lasting congestion among European notified bodies.

Clinical requirements vs performance evidence

This is where the two regulations diverge most fundamentally.

MDR — Clinical evaluation

The manufacturer demonstrates clinical benefits through:

• A critical literature review
• Equivalence with a reference device (rarely applicable in practice)
• A clinical investigation (trial on patients) — almost mandatory for implantables and class III
• Post-market clinical follow-up (PMCF)

IVDR — Performance evidence

No patients are exposed to the device itself — the device analyzes a sample. Performance evidence is therefore organised differently:

• Scientific validity — is the measured analyte genuinely associated with the targeted clinical condition?
• Analytical performance — analytical sensitivity, analytical specificity, accuracy, precision, measuring range
• Clinical performance — diagnostic sensitivity, diagnostic specificity, predictive values

These three components are consolidated in the PER (Performance Evaluation Report), the IVDR equivalent of the CER (Clinical Evaluation Report) under the MDR.

Post-market follow-up is called PMPF (Post-Market Performance Follow-up) — the IVDR equivalent of PMCF.

Notified bodies and procedures

Under the MDR

Manufacturers choose Annex IX, X or XI depending on the class:

• Annex IX — full quality management system
• Annex X — type examination
• Annex XI — product verification

For class I, self-declaration is possible (except classes Im, Is, Ir, which require a notified body for the specific aspect concerned: measuring, sterility, reusable).

Under the IVDR

• Class A — self-declaration (except sterile A, which requires a notified body for sterility)
• Classes B, C, D — mandatory notified body involvement
• Class D — reinforced requirements: European Union reference laboratories (EURL), batch testing surveillance for certain tests

Post-market surveillance: differences

Both regulations require a post-market surveillance system, but with IVDR specifics:

Aspect	MDR	IVDR
Surveillance plan	PMS Plan	PMS Plan
Periodic report	PMS Report (I) or PSUR (IIa, IIb, III)	PMS Report (A, B) or PSUR (C, D)
Field follow-up	PMCF	PMPF
Continuous evaluation	Updated CER	Updated PER
Vigilance	Article 87	Article 82

Transition calendar

The MDR became applicable on 26 May 2021, with a grace period extended to end 2027/2028 depending on class (Regulation 2023/607).

The IVDR became applicable on 26 May 2022. Given the shortage of notified bodies, Regulation (EU) 2024/1860 established staggered transition dates:

• 31 December 2027 — end of validity for class D devices under the former directive
• 31 December 2028 — end of validity for class C
• 31 December 2029 — end of validity for classes B and sterile A

Common mistakes to avoid

1. Believing that medical imaging software is IVDR — no, it is MDR (rule 11). The IVDR only concerns software analyzing a biological sample.
2. Underestimating IVDR reclassification — a test classified as "Other" under the former directive may move to class C, or even D, under the IVDR. Systematically review the classification.
3. Confusing PMCF and PMPF — MDR vocabulary does not apply as-is to the IVDR. Inspectors pay attention to this.
4. Forgetting the European Union reference laboratories for class D — their involvement is mandatory for certain test families.
5. Over- or under-classifying — IVDR classification rests on precise rules (Annex VIII) that must be justified in writing.

Conclusion

The MDR and IVDR share a common architecture but respond to fundamentally distinct logics. Confusing the two frameworks, or worse, handling a device under the wrong regulation, exposes you to penalties and market withdrawal. For a QA/RA team working on a mixed portfolio, the challenge is differentiated monitoring — an MDCG guide for the IVDR does not apply to the MDR, and vice versa.

MedQara automatically classifies each alert by regulatory framework (MDR, IVDR, FDA, ISO…), so you instantly see what concerns your scope.