MDR 2017/745 and medical gloves – what a buyer needs to verify
Most MDR guidance is written for implant manufacturers. This covers gloves: how they are classified, what a notified body actually checked, and the documents to ask a supplier for.
Every medical glove sold in the EU is a regulated medical device under Regulation (EU) 2017/745, the Medical Device Regulation. Most published guidance on MDR is written for manufacturers of implants and software, which is why it rarely helps someone buying gloves. This article covers the part that applies to gloves, and the specific documents to ask a supplier for.
There is one thing to understand before the detail: MDR compliance is not a certificate you can hold up. For most gloves it is a declaration the manufacturer makes on their own authority, backed by a technical file you never see. What you can verify is whether that declaration exists, whether it is current, and whether the standards behind it are the right editions. That is the practical work.
How gloves are classified, and where the ambiguity is
MDR classifies devices into Class I, IIa, IIb and III using the 22 rules in Annex VIII. Class I has three sub-classes that matter here: Is (supplied sterile), Im (measuring function) and Ir (reusable surgical instruments).
Non-sterile examination gloves are Class I. They are non-invasive, in transient contact with intact skin. The manufacturer self-certifies; no notified body is involved. This is uncontroversial and it is what our own examination gloves are declared as.
Sterile surgical gloves are less settled than most sources admit. You will find both answers in reputable places: Class Is, on the basis that a glove is a sterile non-invasive device, and Class IIa, on the basis that it is used in surgically invasive procedures. In practice the majority of surgeons' gloves on the European market are declared Class Is, carrying over the position held under the old Medical Devices Directive.
The distinction is not academic, because it changes who checked what:
So a Class Is glove has had its sterility independently reviewed, not its barrier performance. Do not read a notified body number on a sterile glove box as third-party verification of the whole product.
What to do about it: ask for the declaration of conformity and read the class and rule it states. Do not accept a verbal answer, and do not assume that a competitor quoting a different class is wrong. Where a glove is also personal protective equipment – which most examination gloves are – it carries a second declaration under Regulation (EU) 2016/425, and both apply simultaneously.
What the manufacturer must actually hold
Whatever the class, the obligations behind the CE mark include:
Note what is absent from that list: any requirement for a notified body to have tested the barrier performance of a Class I glove. Which is precisely why the standards documentation matters more than the CE mark.
Where MDR meets EN 455
MDR sets the General Safety and Performance Requirements in Annex I. It does not say how thick a glove must be or how many may leak. Those figures live in the harmonised standards, and this is the link a specification should make explicit.
EN 455-1:2020+A2:2024 and EN 455-2:2024 are harmonised standards under MDR, cited in Commission Implementing Decision (EU) 2025/681. Compliance with them carries presumption of conformity with the corresponding Annex I requirements – but only for those editions. A supplier holding test reports against EN 455-2:2015 or EN 455-1:2020 is outside the presumption, even though the underlying test may be identical.
This is the most common documentation gap we see, and it is invisible unless you check the edition. See our guide to the EN 455 series for what each part covers.
Transition deadlines, corrected
MDR applied from 26 May 2021, but the transition was extended by Regulation (EU) 2023/607 in March 2023 because notified body capacity could not absorb the workload. The revised end dates for legacy MDD-certified devices are:
The extension is conditional: the manufacturer must have an MDR-compliant quality system in place and have lodged a formal application with a notified body by the deadlines set in that regulation. The same regulation removed the previous "sell-off" deadline, so compliant stock already on the market may continue to be supplied.
For gloves this mostly matters when a supplier is still trading on an MDD certificate. Ask which regulation the declaration is made under. "CE marked" alone does not distinguish between them.
What to ask a glove supplier for
This is the list we supply against, and the list we would use to assess any supplier:
1. The declaration of conformity, signed and dated, naming class, Annex VIII rule, and MDR 2017/745 explicitly rather than 93/42/EEC. 2. The EN 455 test reports from an accredited laboratory – parts 1, 2, 3 and 4, with editions stated. Check them against the harmonised list. 3. The manufacturer's EN ISO 13485 certificate, current and naming the actual production site. 4. The Basic UDI-DI and UDI-DIs, and confirmation of EUDAMED registration. 5. The PPE declaration under Regulation (EU) 2016/425 where the glove is dual-purpose, with its category and EN ISO 374 type and code letters. 6. The notified body number and the scope of its involvement for sterile products – specifically, what it assessed. 7. Shelf life substantiation under EN 455-4, not just a printed expiry date. 8. Where the technical file is held and who the Article 15 responsible person is. A supplier who cannot answer this quickly is a supplier whose file may not exist.
A supplier who can produce all eight within a day or two has the system behind the paperwork. One who sends a CE certificate and nothing else usually does not.
Key takeaways
Frequently asked questions
Does a CE mark on a glove box mean a notified body approved it? Not necessarily. For a non-sterile examination glove the CE mark is applied on the manufacturer's own declaration, with no notified body involved. A four-digit number beside the mark indicates a notified body, and for a sterile glove that number generally relates to sterility assessment only.
Is ISO 13485 certification mandatory under MDR? MDR requires a quality management system; it does not name a standard. EN ISO 13485 is the recognised way of demonstrating one, and in practice a manufacturer without it will struggle to evidence compliance.
What is EUDAMED and can I search it as a buyer? EUDAMED is the European database for medical devices, covering registration of actors, devices, certificates, vigilance and market surveillance. Its modules have been rolled out progressively, so public visibility is partial. Where a device is registered, the UDI-DI is the identifier to search on.
Our supplier's declaration cites 93/42/EEC. Is that a problem? It means the declaration is made under the old Medical Devices Directive. That may still be valid within the transition periods above, but it is not an MDR declaration, and you should ask for their MDR transition timeline before committing to a multi-year framework.
Seventeen years sourcing and supplying medical gloves and PPE to governments, UN agencies, NGOs and healthcare systems. Writes on glove standards, quality management and responsible sourcing for institutional buyers, working from the source standards rather than secondary summaries.
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