EU MDR · IFU · Intended purpose
Is your IFU compliant with EU MDR?
Your Instructions for Use are now a regulatory document. Under EU MDR, every claim of intended purpose, benefit and indication must be traceable to clinical evidence, or removed. Here is how to make yours defensible.
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Eclevar MedTech & Milo Health · xShare × EUCROF Open Call
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Reviewed by the people who assess claims.
IFU claims are where clinical evidence meets the reviewer. Ours are pressure-tested by clinicians and former Notified Body reviewers before a Notified Body ever sees them.
Pierre-Marie Boutanquoi
CERs under MEDDEV 2.7/1 Rev 4 and EU MDR; aligning intended purpose, claims and clinical evidence.
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Dr Mark Da Costa
Former lead Notified Body reviewer at TÜV SÜD. 400+ devices CE-certified.
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Europe’s best-rated medical device CRO.
Platinum Award 2026
Top tier at the xShare × EUCROF Open Call, awarded to Eclevar MedTech and its Milo Health platform, presented at EUCROF 2026 in Amsterdam.
The announcement →Co-funded by the European Union
Selected through the xShare Open Call for clinical research innovation, Horizon Europe.
xShare results →Independently reported
Distinction confirmed by an independent third party, the CVBF, also an awardee of the xShare × EUCROF Open Call.
CVBF coverage →What this guide covers
The IFU, from intended purpose to defensible claims.
The requirements
From a marketing document to a clinical one.
The European regulatory landscape has shifted profoundly. The IFU is no longer a leaflet, it is the bridge between the clinical evidence and what you tell users the device does, and every word of it can be challenged.
01 / 06
Why the IFU is now a regulatory document
Manufacturers must ensure their Instructions for Use clearly communicate the device’s intended purpose, clinical benefits, indications, conditions of use and contraindications — all supported by robust clinical evidence. The IFU is where the clinical evaluation becomes visible to the user, and to the reviewer.
02 / 06
Intended purpose: from MDD to MDR
The definition of intended purpose has been refined, and the change matters.
The old definition
“The use for which the device is intended according to the data supplied by the manufacturer on the labeling, in the instructions and/or in promotional materials.”
The expanded definition
The use for which a device is intended according to the label, IFU, promotional or sales materials or statements, and as specified by the manufacturer in the clinical evaluation.
The expansion is the point: intended purpose must be communicated consistently across every material and must be substantiated by clinical evaluation.
03 / 06
What Article 61 and Annex XIV require
Article 61 and Annex XIV, with clarifications from MDCG 2020-5 and 2020-6, set what the clinical evaluation must do to back the IFU.
The clinical evaluation must
- Clearly identify the intended purpose, clinical benefits, conditions of use and specific contraindications
- Ensure the available clinical evidence justifiably supports all claims made in the IFU
- Establish outcomes achievable with other state-of-the-art (SOTA) therapies for the same population and indication
- Determine benchmarks for safety, performance and benefit-risk
- Define measurable parameters, endpoints and acceptable outcomes
04 / 06
Intended purpose vs indications
Article 2(12) keeps the definition of intended purpose from the Directives, and Annex I Section 23.4 confirms the intended purpose includes indications, where they exist. But per MDCG 2020-6, an indication is the clinical condition being diagnosed, prevented, treated or controlled — while intended purpose describes the device’s effect. All devices have an intended purpose; not all have an indication (for example, a device for disinfection or sterilisation).
05 / 06
What your IFU must contain
A compliant IFU starts from a clear, comprehensible description of the intended purpose and the standard of care, then flows into everything else.
Intended purpose defines
- The target patient population and clinical condition
- The clinical benefits and therapeutic outcomes
- Conditions of use: setting, operator qualifications, patient characteristics
- Contraindications and warnings
- Performance expectations, safety parameters and the clinical evidence required
06 / 06
How to make every claim defensible
The test is simple and unforgiving: can the clinical evidence justify each IFU claim against the state of the art, with a defined endpoint and an acceptable outcome? Where it can, we document the link explicitly. Where it cannot, the claim is a Notified Body deficiency waiting to happen and must be substantiated or removed. Our medical writers align the clinical evaluation report and the IFU so a reviewer can trace every claim end to end.
The IFU test
Every claim, traced to evidence.
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Book a free IFU reviewAn IFU claim you can’t defend is a deficiency you haven’t found yet.
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