EU MDR · Borderline · Drug-device
Is your nasal spray a device, a drug, or a combination?
The answer decides your entire regulatory pathway under EU MDR 2017/745. It hinges on one thing: the principal mechanism of action. Here is the decision, and the CER and PMCF that follow.
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Platinum Award 2026
Eclevar MedTech & Milo Health · xShare × EUCROF Open Call
Led by authority
Borderline calls, made by former reviewers.
A wrong classification restarts the whole programme. Ours is confirmed by clinicians and former Notified Body reviewers who have argued these cases.
Dr Mark DaCosta
Former lead Notified Body reviewer at TÜV SÜD; borderline and drug-device combination assessment.
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Pierre-Marie Boutanquoi
CERs and classification rationales under EU MDR and MEDDEV 2.7/1 Rev 4.
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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 →The first question
Mechanism of action decides everything.
The classification of a nasal spray depends entirely on its principal intended mechanism of action — the most consequential decision in the product’s lifecycle. It determines whether EU MDR or Directive 2001/83/EC applies, and shapes every subsequent regulatory, clinical and commercial choice.
→ Medical device
A saline spray that works by mechanically flushing the nasal cavity, or by creating an osmotic gradient to hydrate mucus, acts physically. It is a medical device under EU MDR 2017/745.
→ Medicinal product
A corticosteroid spray that reduces inflammation via pharmacological action is a medicinal product under Directive 2001/83/EC. The active ingredient, not the format, drives this.
The mechanism — not the formulation or the active ingredient — determines the classification.
The second question
Rule 13 vs Rule 21.
Rule 13
Drug-device combination
If the nasal spray is primarily a device but contains a drug substance (e.g. hyaluronic acid, or xylometazoline at a sub-therapeutic dose) whose action is ancillary to the device function, it is a drug-device combination governed by Rule 13 of Annex VIII. This typically results in Class III and requires consultation with a medicines competent authority on the ancillary substance.
Rule 21
Substance-based device, no drug component
If there is no drug component, Rule 21 applies to substance-based devices. Classification then depends on where the substance acts and whether it is absorbed — ranging from Class IIa up to Class III for substances absorbed systemically. Substance-based devices face heightened scrutiny of absorption and safety.
03
The CER and the claims
Once classified as a device, the nasal spray needs a Clinical Evaluation Report under Article 61 that justifies the intended purpose and every label claim against the state of the art. For higher classes, a clinical investigation may be required, and the IFU claims must be traceable to the evidence.
04
PMCF obligations
Like any device, a nasal spray medical device needs Post-Market Clinical Follow-up proportionate to class and risk, confirming ongoing safety and performance and feeding the periodic update of the clinical evaluation.
The decision at a glance
One question sets the whole path.
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