In our medical device registration consulting work we have found a very common misconception: simple collection products such as disposable urine bags and emergency vomit bags are often wrongly classified by companies as MDR Class IIa.
This misunderstanding is not only widespread; once a product is misclassified, it causes:
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Costs that can be dozens of times higher
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A huge increase in the complexity of the technical documentation
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A registration timeline that may grow from 1 month to 6–12 months
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Most NBs (notified bodies) will not accept unwarranted Class IIa applications
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Mistakes may make you look as if you “don’t understand the MDR”, damaging your credibility for future cooperation
So how should these products be classified under the EU MDR? Why do so many companies misclassify them as IIa? And what is the correct answer?
1. MDR classification logic: understanding the “underlying logic” of the classification rules
The EU MDR (Regulation (EU) 2017/745) uses a risk-based classification system. The core logic is:
Lower risk → lower class (Class I); higher risk → higher class (Class IIa/IIb/III)
Disposable urine bags and vomit bags are fundamentally very simple:
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External use
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Non-invasive
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Not connected to any device
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Not involved in diagnosis or treatment
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Not part of a body fluid management system
Logically they should be classified as Class I. So why do so many companies misclassify them as IIa?
2. The source of the error: misunderstanding MDR Rule 2
90% of misclassifications in the industry stem from the following rule:
MDR Annex VIII Rule 2 — original English text
“All non-invasive devices intended for channeling or storing substances, fluids or gases, for introduction into or for extraction from the body, shall be classified as class IIa…”
Chinese translation
“All non-invasive devices intended for channelling or storing blood, body liquids, cells or tissues, liquids or gases for the purpose of (1) eventual infusion, administration or introduction into the body, or (2) [extraction from the body],
are classified as Class IIa.”
Many companies only see the keywords:
storing bodily fluids → storage of body fluids → IIa. But they overlook that the most important qualifying condition in Rule 2 is use in a process of introduction into or extraction from the body. Disposable urine bags and vomit bags:
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Are not involved in infusion
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Are not involved in drainage
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Are not connected to any tubing
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Are not involved in any clinical procedure
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Merely passively collect body fluids “after they have already left” the patient
They clearly do not meet Rule 2.
3. The correct classification: MDR Class I (under Rule 1). Let’s look at the basic MDR rule – Rule 1.
MDR Annex VIII Rule 1 — original English text
“All non-invasive devices are classified as class I, unless one of the rules set out hereinafter applies.”
Chinese translation
“All non-invasive devices are classified as class I, unless one of the rules set out hereinafter applies.”
Urine bags and vomit bags are clearly:
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Non-invasive
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Non-active
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Not involved in clinical fluid management
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Not used for introduction into or extraction from the body
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Not connected to catheters or equipment
Therefore Rule 1 applies → Class I
This is exactly the “basic logic” of the MDR classification system.
4. Official MDCG guidance also clearly supports Class I rather than IIa
MDCG 2021-24 “Guidance on classification of medical devices” clearly states:
MDCG excerpt (English)
“Simple non-invasive collection devices for urine, stools or vomit, not forming part of a body fluid management system, are generally Class I.”
Chinese translation
“Simple non-invasive collection devices for urine, faeces or vomit that are not part of a clinical fluid management system are generally classified as Class I.”
This sentence could almost have been written specifically for disposable urine bags and emergency vomit bags.
5. Why do companies get it wrong? (Summary of common industry mistakes)
Companies must therefore clearly explain in their technical documentation:
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Why Rule 2 does not apply
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Why Rule 1 is the correct classification
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How they demonstrate that the product is not involved in clinical fluid management
This is the core of the Classification Justification in the technical documentation.
6. Final conclusion (can be used as the basis for your registration)
✔ Disposable urine bags
➡ MDR Class I (Rule 1)
✔ Disposable emergency vomit bags
➡ MDR Class I (Rule 1)
✔ If the product is supplied sterile
➡ Class Is (the NB reviews only the sterilisation aspects)
No higher-level NB review is required.
7. Professional support from EVERBIZ
As a consultancy specialising in EU regulations and global registration systems, EVERBIZ offers companies:
End-to-end MDR / IVDR compliance support
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Classification Justification
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GSPR (General Safety and Performance Requirements) checklist
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Clinical Evaluation Report (CER)
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Preparation and review of technical documentation (TD/Technical File)
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Post-market documentation such as PMS and PMCF
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Authorized representative services
Handling of classification disputes
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Expert Rule 1 vs Rule 2 analysis
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Communicating the classification rationale with the NB
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Correcting misclassification and optimising technical documentation
MDR applicability analysis
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Medical device vs non-medical product determination
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Resolving borderline disputes
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GSPR conformity assessment
Lightweight registration solution (Class I products)
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DoC (Declaration of Conformity)
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CE marking requirements
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Essential pre-market TD (technical documentation)
If you are preparing an MDR registration or would like a further assessment of your product’s classification, please contact EVERBIZ at any time. We will provide the most professional and reliable compliance route.
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