EU Authorized Representative for Examination and Surgical Glove Manufacturers: Class I Under the MDR, and Why the PPE Side Is Separate
Medical gloves are among the simplest devices the MDR covers and among the hardest to place on the Union market correctly. The classification is easy: class I, self-declared, sterile versions aside. Everything else is not. A glove sold for both clinical and protective use falls under two separate regulations at once — and they do not share a representative, a notified body or a route. Its latex status is a UDI database field that can force a new identifier. And its manufacturer, almost always outside the Union, cannot place a single box on the market without an authorized representative under Article 11(1).
Two rules, one answer
Glove classification is argued more often than it needs to be, because two rules in Annex VIII can be read onto the same product.
Rule 1 is the residual rule for anything that does not penetrate the body:
"All non-invasive devices are classified as class I, unless one of the rules set out hereinafter applies."
Rule 4 catches non-invasive devices that touch damaged tissue:
"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;"
An examination glove that contacts a mucous membrane during an examination sits in Rule 4, and a glove is by definition a mechanical barrier — so Rule 4 returns class I. A glove used only against intact skin sits in Rule 1, which also returns class I. Both roads arrive at the same place, which is why the argument is usually academic. It stops being academic if your intended purpose claims anything beyond barrier function: a glove marketed as managing the wound micro-environment, or as delivering a substance to the skin, leaves the first indent of Rule 4 and can land in class IIa.
Write the intended purpose as a barrier, and keep the marketing copy consistent with it. Sales language that promises a therapeutic effect has reclassified more than one glove file.
The sterile line
Non-sterile examination gloves are self-declared end to end. Sterile surgical gloves are still class I, but Article 52(7) attaches a limited notified body procedure:
"If those devices are placed on the market in sterile condition, have a measuring function or are reusable surgical instruments, the manufacturer shall apply the procedures set out in Chapters I and III of Annex IX, or in Part A of Annex XI. However, the involvement of the notified body in those procedures shall be limited: (a) in the case of devices placed on the market in sterile condition, to the aspects relating to establishing, securing and maintaining sterile conditions;"
The notified body looks at sterilization validation, packaging integrity, shelf life and the sterile barrier system. It does not look at your polymer, your AQL, your protein content or your labelling in general. Those remain yours to defend.
| Product | Class | Notified body | What the file needs |
|---|---|---|---|
| Non-sterile examination glove | I | None | Annexes II & III, DoC, UDI, EUDAMED |
| Sterile surgical glove | I (Is) | Limited — sterility only | The above, plus sterilization validation, sterile barrier and shelf-life data |
| Glove also sold as PPE | I under MDR, plus category III under PPE | MDR: none (non-sterile). PPE: notified body, module B + C2 or D | Two separate files, two separate representative arrangements |
The second regulation, and why one appointment cannot answer both
A glove sold to protect the wearer from biological agents is personal protective equipment under Regulation (EU) 2016/425. Annex I to that Regulation puts "harmful biological agents" in category III — the tier reserved for risks that may cause death or irreversible damage to health. Category III cannot be self-declared. Article 19(c) routes it to "EU type-examination (module B) set out in Annex V", followed by supervised product checks (module C2) or production quality assurance (module D).
Most examination gloves are sold on both claims: protect the patient, protect the clinician. When both claims appear on the box, both regulations apply to the same product, and the two assessments are not interchangeable. The device side may be self-declared class I while the PPE side needs a notified body.
The representative arrangements do not line up either, and this is where manufacturers assume too much. Under the MDR, appointing an authorized representative is compulsory for a manufacturer established outside the Union. Under the PPE Regulation it is optional:
"A manufacturer may, by a written mandate, appoint an authorised representative."
Two further differences matter. The PPE Regulation defines an authorised representative as a person "established within the Union", so the EU–Türkiye Customs Union arrangement that applies on the medical device side does not reach it. And a PPE mandate carries its own, shorter task list under Article 9(2) — keeping the declaration and technical documentation available for ten years, answering reasoned requests, and cooperating on risk-elimination measures — not the Article 11(3) list.
So there is no single appointment that satisfies both regulations. What we hold is the MDR mandate. If your glove also carries a protective claim, that side needs its own notified body and, should you choose to appoint one, its own representative established in the Union.
Decide the claim before you print the box. If the glove is not intended to protect the wearer, do not put that on the packaging — and if it is, budget for the second route from the start.
Latex is a UDI database field, not a footnote
Annex VI Part B lists the data elements a device record carries in the UDI database. Item 20 is:
"containing latex (y/n)"
And Annex VI Part C treats it as an identity-bearing attribute — a change in "critical warnings or contra-indications: e.g. containing latex or DEHP" requires a new UDI-DI, not an update to the existing one.
The practical effect is that a natural rubber latex glove and its nitrile equivalent are not two variants of one record. They are separate device identifiers, and a manufacturer who switches a line from latex to nitrile without issuing a new UDI-DI has broken the traceability the Regulation is built on. Glove ranges change material more often than almost any other device category, so this is a recurring failure rather than a one-off.
The standards an assessment will look for
The EN 455 series is the reference family for single-use medical gloves: freedom from holes, physical properties, biological evaluation, and shelf-life determination. Nothing in the MDR obliges you to use a harmonised standard, but a file that departs from EN 455 has to explain what it used instead and why the general safety and performance requirements in Annex I are met by that route. In practice, files that do not cite EN 455 get long questions.
Powder residue, extractable protein and endotoxin limits sit in the same family. If you sell a powdered glove into the Union, the risk file has to address the powder specifically — it is not a neutral processing aid in a device that contacts mucous membrane.
Who is the manufacturer when the box carries your customer's brand
Very few gloves reach the Union under the name of the plant that made them. The MDR is indifferent to who owns the dipping line: the manufacturer is the party that places the device on the market under its own name or trade mark. If the box says your brand, you own Annexes II and III, you issue the declaration of conformity, and you appoint the authorized representative.
If the box says a European buyer's brand, that buyer is the manufacturer and is established in the Union, so no authorized representative is needed for those units. A plant running both models needs two files and two answers, and needs to know which containers carry which.
An importer is not a substitute for either. Importer obligations are separate obligations, and an importer that puts its own name on the box has become a manufacturer without meaning to.
Volume, and what it does to registration
Glove exporters ship in a small number of device families and a large number of SKUs — sizes, colours, thicknesses, textures, powdered and powder-free. Grouping matters more here than in any other class I category. Sizes of the same glove sit under one Basic UDI-DI; a material change does not, as above. Getting this grouping right at registration is cheaper than correcting a EUDAMED record afterwards, and the corrections queue is not fast.
What our mandate covers for glove manufacturers
The full Article 11(3) task list, in writing, for at least one whole generic device group — the Regulation does not permit a narrower mandate. Before we accept it we read your declaration of conformity, your Annex II and III documentation, your EN 455 test reports and, for sterile lines, your sterilization validation. We do this because Article 11(5) makes an authorized representative jointly and severally liable with a manufacturer that has not met Article 10. We would rather tell you what is missing than share liability for it.
A frequent question at this point is whether the Union and Türkiye need separate representatives. They do not. Article 11(1) requires a sole authorised representative for the devices concerned, and under the EU–Türkiye Customs Union arrangement that representative may be established in the Union or in Türkiye. One appointment, covering the Union market and Türkiye — not one for each. Our registered place of business is in Türkiye and our EUDAMED authorized representative identifier is TR-AR-000057550; the arrangement is set out in the European Commission's Notice to Stakeholders of March 2022 and described in MDCG 2022-16.
Where you are established changes the starting point
The classification above is the same wherever the instrument is made. What differs by country is everything around it: the national approval you already hold and what it does not carry into the Union, the authentication route your documents have to travel, and whether your European customers expect you or them to hold the CE file. We keep a separate page for each of the main exporting countries in this sector — Malaysia, Thailand and China.
If your country is not listed there, the mandate works the same way; send your device list and we will tell you which route applies. A full list of the categories we cover is on the device category page.
Frequently asked questions
Are examination gloves class I or class IIa?
Class I. Whether you read them under Rule 1 or under the first indent of Rule 4, a glove intended as a mechanical barrier is class I. It moves up only if the intended purpose claims something beyond barrier function.
Do I need a notified body for gloves?
Not for non-sterile gloves under the MDR. Sterile gloves need a notified body for sterility aspects only. If the glove is also sold as protective equipment against biological agents, the PPE Regulation route needs a notified body separately.
Do I still need an EU authorized representative if my gloves are self-declared?
Yes. Article 11(1) depends on where the manufacturer is established, not on the device class or the assessment route.
We changed our range from latex to nitrile. Do we need new registrations?
You need new UDI-DIs. Latex content is a UDI database data element and a change to it is treated as a change requiring a new device identifier, not an amendment.
Does your mandate also cover the PPE side of our gloves?
No. Our mandate is the MDR one under Article 11. The PPE Regulation has its own authorised representative concept, it is optional rather than compulsory, and it requires a person established within the Union — the Customs Union arrangement with Türkiye does not extend to it.
Can our EU importer act as our authorized representative?
Importer and authorized representative are separate roles with separate obligations, and the mandate carries Article 11(5) joint liability. Most importers decline once they understand what they are accepting.
How fast can we be on the market?
Once your file is complete, the mandate can be signed and your actor registration verified quickly. What takes time is the file — usually the sterilization validation or the missing biocompatibility report, not the mandate.
Sources and further reading
Regulation (EU) 2017/745 (MDR), consolidated text — Article 11, Article 52(7), Annex VI Parts B and C, Annex VIII Rules 1 and 4 — EUR-Lex, CELEX 02017R0745-20230320
Regulation (EU) 2016/425 on personal protective equipment — Article 3(5), Article 9, Article 19, Annex I — EUR-Lex
European Commission, health.ec.europa.eu — medical devices, EUDAMED
MDCG 2022-16; European Commission Notice to Stakeholders, March 2022
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