EU Authorized Representative for Wound Dressing Manufacturers: Rule 4 Classes, Claims and the Mandate
Wound dressings are classified under Rule 4 of Annex VIII, and the class follows the claim, not the material. A dressing that acts as a barrier or absorbs exudate is class I, one that manages the micro-environment of a wound is class IIa, and one intended principally for wounds that have breached the dermis and heal only by secondary intent is class IIb. A dressing with an ancillary medicinal substance is class III. A manufacturer outside the Union needs a sole authorised representative under Article 11 in every case.
Rule 4 sets the class of a dressing
Dressings are non-invasive devices that contact injured skin, which brings them under Rule 4:
"Rule 4 All non-invasive devices which come into contact with injured skin or mucous membrane are classified as: — class I if they are intended to be used as a mechanical barrier, for compression or for absorption of exudates; — class IIb if they are intended to be used principally for injuries to skin which have breached the dermis or mucous membrane and can only heal by secondary intent; — class IIa if they are principally intended to manage the micro-environment of injured skin or mucous membrane; and — class IIa in all other cases." (MDR Annex VIII, Rule 4)
The rule also reaches devices used inside body orifices:
"This rule applies also to the invasive devices that come into contact with injured mucous membrane." (MDR Annex VIII, Rule 4)
The claim decides, not the material
MDCG 2021-24 Rev.1 is explicit that the same material can sit in different classes: a polymeric film dressing is class IIa where it is intended to manage the micro-environment of the wound, and class I where its intended use is limited to retaining an invasive cannula at the wound site. The guidance adds that it is impossible to assign a type of dressing to a class without knowing the intended use, and that a claim that the device is interactive or active with respect to the wound healing process usually implies at least class IIa.
Intended purpose is read from everything the manufacturer publishes:
"‘intended purpose’ means the use for which a device is intended according to the data supplied by the manufacturer on the label, in the instructions for use or in promotional or sales materials or statements and as specified by the manufacturer in the clinical evaluation;" (MDR Article 2(12))
A brochure describing faster healing, moist wound healing or suitability for ulcers and burns can therefore move a dressing up a class even where the instructions for use are cautious.
Examples from MDCG 2021-24 Rev.1
| Dressing and intended purpose | Rule relied on | Class | Notified body |
|---|---|---|---|
| Absorbent pads, island dressings, cotton wool, wound strips, adhesive bandages and gauze acting as a barrier or absorbing exudate, non-sterile | Rule 4, first indent | I | No |
| The same dressings supplied sterile | Rule 4, first indent | I (sterile, "Is") | Yes, limited to sterility |
| Dressings for nose bleeds | Rule 4, first indent | I | No |
| Hydrogel dressings, non-medicated impregnated gauze and polymer film dressings managing the wound micro-environment | Rule 4, third indent | IIa | Yes |
| Dressings for ulcerated wounds or burns that have breached the dermis, dressings for severe decubitus wounds | Rule 4, second indent | IIb | Yes |
| Dressings incorporating means of augmenting tissue and providing a temporary skin substitute | Rule 4, second indent | IIb | Yes |
| Dressings incorporating a substance that would be a medicinal product if used separately, with ancillary action | Rule 14 | III | Yes |
MDCG 2021-24 Rev.1 notes that devices composed of other substances which are absorbed by or locally dispersed in the human body fall under Rule 21 rather than Rule 4.
Medicinal substances and animal tissue
A dressing that contains an antimicrobial or other substance acting ancillary to the dressing moves to class III under Rule 14, and the notified body must consult a medicines authority on the substance. Dressings made from tissues or derivatives of animal origin, such as collagen of animal origin, fall under Rule 18:
"Rule 18 All devices manufactured utilising tissues or cells of human or animal origin, or their derivatives, which are non-viable or rendered non-viable, are classified as class III, unless such devices are manufactured utilising tissues or cells of animal origin, or their derivatives, which are non-viable or rendered non-viable and are devices intended to come into contact with intact skin only." (MDR Annex VIII, Rule 18)
A dressing for injured skin does not meet the intact-skin exception, so an animal-derived wound dressing is class III, and Regulation (EU) No 722/2012 applies where the tissue comes from an animal species that regulation covers. Where silver or another component is present as a nanomaterial, Rule 19 must also be checked. Both points should be settled before the classification of a wound care range is fixed, because they change the conformity assessment route and the evidence needed.
Class I dressings still carry obligations
For non-sterile class I dressings the manufacturer draws up the technical documentation and the EU declaration of conformity under Article 52(7) without a notified body. Sterile class I dressings need a notified body for the sterile aspects under the same paragraph. The technical documentation includes a biological evaluation, where EN ISO 10993-1:2025 is cited as a harmonised standard, risk management under EN ISO 14971:2019, a clinical evaluation supporting each claim, and a post-market surveillance plan. The device needs a Basic UDI-DI and registration in EUDAMED under Article 29.
What Medex does under the mandate
Article 11(1) applies to every class of dressing:
"Where the manufacturer of a device is not established in a Member State, the device may only be placed on the Union market if the manufacturer designates a sole authorised representative." (MDR Article 11(1))
Medex Kurumsal Danışmanlık acts as authorised representative under EUDAMED SRN TR-AR-000057550. Under the mandate we verify that the EU declaration of conformity and technical documentation have been drawn up and that any required notified body procedure has been carried out; keep copies at the disposal of competent authorities; complete our own actor registration and check your UDI and device registrations; forward authority requests; cooperate on corrective actions; and pass on complaints and incident reports without delay. A person responsible for regulatory compliance is available in-house, as Article 15(6) requires.
The European Commission's Notice of March 2022 confirms that manufacturers outside the EU and Türkiye "only need to designate one authorised representative, either in the EU or in Turkey", so one Medex mandate covers both markets. Offices in Ankara, İstanbul and Gdańsk.
Annual fees range from €800 for class I to €2,000 for class III, with a €0 setup fee and €150 for a change of representative. We do not write technical documentation or clinical evaluations, we are not a notified body, and we do not find distributors or act as a Swiss or UK representative. We reply within one business day.
Related device categories and country pages
We keep separate pages for other device groups, including examination and surgical gloves, kinesiology tape and orthoses, braces and supports. All groups are listed on the medical device categories page. Most of the manufacturers we represent are based in China, Türkiye, India and South Korea; the full list is on the EU authorized representative by country page.
To check how Annex VIII applies to your own device, use our free MDR classification checker. It walks through rules 1 to 22 and quotes the rule text behind every result.
If your device is still placed on the market under an MDD, AIMDD or IVDD certificate or declaration, the free MDR and IVDR transition deadline checker shows the Article 120 or Article 110 date that applies and the conditions it depends on.
Frequently asked questions
Is plain gauze a class I device?
Yes, when it is intended as a mechanical barrier or to absorb exudate. Supplied sterile, it remains class I but needs a notified body for the sterile aspects under Article 52(7).
Why is our hydrogel dressing class IIa?
MDCG 2021-24 Rev.1 lists hydrogel dressings as class IIa because they are principally intended to manage the micro-environment of the wound. If the claims extend to wounds that have breached the dermis and heal only by secondary intent, class IIb must be considered.
What class is a silver dressing?
It depends on the role of the silver. Where the silver is a substance that would be a medicinal product if used separately and acts ancillary to the dressing, Rule 14 places the dressing in class III.
Does one mandate cover the European Union and Türkiye?
Yes. Under the EU–Türkiye Customs Union arrangement described in the Commission Notice of March 2022, a manufacturer outside both needs one authorised representative, established in the EU or in Türkiye.
Sources
Regulation (EU) 2017/745 on medical devices, consolidated text — eur-lex.europa.eu
MDCG 2021-24 Rev.1, Guidance on classification of medical devices (April 2026) — health.ec.europa.eu
European Commission, Summary list of harmonised standards (Regulation (EU) 2017/745) — single-market-economy.ec.europa.eu
European Commission, Notice to Stakeholders: EU-Turkey Customs Union Agreement in the field of medical devices (March 2022) — health.ec.europa.eu
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Other device categories
We also cover reusable surgical instruments, condoms, wheelchairs and mobility aids, spectacle frames and ophthalmic optics and orthoses, braces and supports. The full list is on the device categories page, and country pages are in the list by country.
If your devices still need to be registered in EUDAMED, see our EUDAMED registration proposal.