Is your nasal spray a medical device, a medicinal product, or a drug-device combination? The answer determines your entire regulatory pathway under EU MDR 2017/745. This guide covers Rule 13 and Rule 21 classification, CER requirements, and PMCF obligations for nasal spray medical devices.
The classification of a nasal spray under EU MDR 2017/745 depends entirely on the principal intended mechanism of action. This is the most consequential decision in the product's regulatory lifecycle — it determines whether EU MDR or Directive 2001/83/EC (medicinal products) applies, and shapes every subsequent regulatory, clinical, and commercial decision.
Two classification rules in Annex VIII of EU MDR 2017/745 are most relevant to nasal spray medical devices. Understanding which applies — and why — is critical before engaging a Notified Body for conformity assessment.
| Classification rule | What it covers | Resulting class | NB involvement | Example nasal spray |
|---|---|---|---|---|
| Rule 21 — Substances | Devices composed of substances or combinations of substances that are locally dispersed in or on the human body and absorbed by, or locally dispersed in, the human body. | Class IIa (minimum) | Required. Annex IX Section 5.4 procedure applies — NB must consult a medicines competent authority. | Isotonic saline nasal spray. Hypertonic saline irrigation. Xylitol-based nasal rinse. |
| Rule 13 — Drug-device combination | Devices incorporating or composed of a substance that, when used separately, would be considered a medicinal product — and the substance has an action ancillary to the principal device mode of action. | Class III | Required. Mandatory consultation with a medicines competent authority for the drug component. Most demanding conformity assessment pathway. | Nasal spray combining saline irrigation with low-dose decongestant. Nasal spray with antimicrobial drug component. |
| Co-packaged drug + device | A medicinal product (nasal spray) co-packaged or co-presented with a separate medical device (delivery system). Each component is regulated under its own framework. | Separate pathways | NB for the device component. Medicines authority for the drug component. Two parallel regulatory submissions. | Corticosteroid nasal spray (medicinal) co-packaged with a nasal rinse device (medical device). |
A CER under EU MDR 2017/745 and MDCG 2020-13 is required for all CE-marked medical devices, including nasal spray medical devices. The CER must be proportionate to the device's risk class and the nature of the clinical claims — but "proportionate" for a Class IIa substance-based device still requires a systematic, structured evaluation.
The CER for a nasal spray medical device must demonstrate that the device achieves its intended purpose — as described in the labelling and instructions for use — and that the associated residual risks are acceptable in relation to the clinical benefits. For nasal sprays, this means establishing clinical evidence for the specific indication claimed, at the specific concentration and formulation used.
Broad claims such as "relieves nasal symptoms" require clinical evidence across the full range of intended indications — allergic rhinitis, chronic rhinosinusitis, post-operative nasal care, rhinitis of pregnancy, and acute rhinosinusitis are distinct clinical conditions with distinct evidence requirements. A single literature review covering one indication does not satisfy the CER requirements for all claimed indications.
The systematic literature review (SLR) in the CER must follow a pre-specified protocol with defined search strategy, inclusion/exclusion criteria, and quality appraisal methodology. The search must cover saline nasal irrigation evidence specifically — not just nasal spray evidence in general. MEDLINE, Embase, and Cochrane databases are minimum requirements.
Under EU MDR 2017/745 Article 7, all clinical claims in labelling, instructions for use, and marketing materials must be based on sufficient clinical evidence and must not be misleading. For nasal spray medical devices, this means every performance claim — including "clinically proven," "reduces nasal congestion," or "proven mucociliary transport improvement" — must be backed by published clinical evidence at the appropriate level of quality.
Quantitative performance claims require quantitative clinical evidence. A claim that a saline nasal spray "reduces congestion score by X points" cannot rely on expert opinion or pre-clinical data alone. The CER must contain Level I or Level II clinical evidence supporting any quantified claim.
The CER must address residual risks that remain after all risk mitigation measures have been applied. For nasal spray medical devices, this includes:
These risks must be communicated in the product labelling under Annex I Chapter III Point 23.1(g) of EU MDR 2017/745.
As Class IIa devices (at minimum), nasal spray medical devices are subject to Post-Market Clinical Follow-Up (PMCF) requirements under Annex XIV Part B of EU MDR 2017/745. The PMCF Plan must address specific clinical data gaps identified in the CER — it cannot be a generic document.
For nasal spray medical devices with an established clinical evidence base, a high-quality Level 4 PMCF survey is typically the most appropriate and proportionate PMCF activity. The survey must use validated, indication-specific questionnaires (e.g. SNOT-22 for rhinosinusitis, NOSE scale, VAS symptom scoring) and must be conducted at clinical sites with confirmed device use, not via consumer panels or online surveys.
Level 4 surveysFor devices with significant unresolved CER data gaps — for example, a nasal spray with a novel formulation or a new clinical indication — a prospective observational PMCF study may be required. The study must comply with ISO 14155:2020 and require ethics committee approval, even though it is a post-market study. Eclevar manages observational programs across France, UK, and Germany with in-house CRA monitoring.
PMCF guideThe PMCF Report summarising PMCF activity findings feeds into the annual CER update. For Class IIa nasal spray devices, the CER must be reviewed annually and updated when new clinical evidence changes the benefit-risk conclusion. The PMCF Report and updated CER are reviewed by the Notified Body at each surveillance audit. A PMCF Report that does not address the specific data gaps from the CER is a primary Notified Body finding.
EU MDR 2017/745 Article 7 prohibits misleading information in device labelling, instructions for use, and marketing materials. For nasal spray medical devices, this is a primary compliance risk area — marketing-driven claim language consistently fails to meet the clinical evidence standard that Notified Bodies now apply.
Under EU MDR, every clinical performance claim must be substantiated by clinical evidence of sufficient quality. For nasal spray devices, permitted claims are those directly supported by the clinical evidence in the CER — typically at Level IIb or above for quantified outcomes. Claims must be device-specific, not extrapolated from general product category literature.
After the pre-clinical phase and feasibility assessment, the clinical evidence pathway for a nasal spray medical device typically follows this sequence: systematic literature review to establish the existing evidence base, identification of specific data gaps for the claimed indications and patient populations, selection of the PMCF methodology to address those gaps, and ongoing PMCF activity generating new clinical data.
For novel nasal spray formulations without a direct literature equivalent, a pre-market clinical investigation may be required before CE marking — particularly for Class IIb drug-device combinations under Rule 13, where the clinical evidence bar is significantly higher and the Notified Body scrutiny most demanding.
A nasal spray is classified as a medical device under EU MDR 2017/745 if its principal intended action is achieved through physical or mechanical means — for example, a saline spray that irrigates the nasal cavity through osmotic or mechanical flushing action. If the principal action is pharmacological, immunological, or metabolic, the product is a medicinal product governed by Directive 2001/83/EC. Borderline cases should be resolved using MDCG 2022-5 before engaging a Notified Body.
Nasal spray medical devices are classified as Class IIa at minimum under Rule 21 of Annex VIII of EU MDR 2017/745, which covers devices composed of substances locally dispersed in the human body. If the nasal spray contains a drug component with an ancillary function to the device action, Rule 13 may elevate the classification to Class III. Both classifications require Notified Body involvement in the conformity assessment, plus mandatory consultation with a medicines competent authority under Annex IX Section 5.4.
Yes. As a Class IIa or IIb device, nasal spray medical devices are subject to PMCF requirements under Annex XIV Part B of EU MDR 2017/745. The PMCF Plan must address specific clinical data gaps from the CER. For most nasal spray devices with an established literature base, a Level 4 PMCF survey using validated outcome instruments (SNOT-22, NOSE scale) is the most proportionate activity. For novel formulations or indications, a prospective observational study may be required.
A CER for a nasal spray medical device under EU MDR 2017/745 must include: a systematic literature review with pre-specified search protocol covering all claimed indications, clinical performance data demonstrating that the device achieves its intended purpose, adverse event and safety data, a residual risk analysis, and a PMCF Plan addressing unresolved data gaps. Every clinical claim in the device labelling must be explicitly supported by clinical evidence cited in the CER. Quantified claims require quantified evidence at Level IIb or above.
Pages linking to and from this guide — building authority for the clinical evaluation nasal spray EU MDR cluster.
Eclevar MedTech's regulatory team provides written classification opinions for borderline nasal spray products before any conformity assessment work begins — preventing costly misclassification errors. Our former Notified Body reviewer reviews CERs for substance-based devices with the same standards a Notified Body assessor will apply.
