EU MDR and Medical Devices – What Applies to Gloves?

From MDD to MDR – what changed?

MDD (Medical Device Directive 93/42/EEC) was the old directive that regulated medical devices in the EU. It was a directive – meaning each EU country implemented it in national legislation.

MDR 2017/745 (Medical Device Regulation) fully replaced the MDD from May 2021. MDR is a regulation – it applies directly in all EU countries without national implementation.

Most important changes for glove suppliers:

Classification rules for gloves

Under MDR, medical devices are classified according to risk-based rules in Annex VIII. For gloves there is one primary rule.

Rules 1 and 6 – the two relevant classification rules

Rule 1 – Non-invasive devices:

Examination gloves touch the skin from the outside and are non-invasive. They are classified by default as Class I under MDR Annex VIII, Rule 1.

Rule 6 – Surgically invasive devices for short-term use:

Surgical gloves are considered surgically invasive because they are used during operative procedures and are in direct contact with open wounds and the operative field. Rule 6 states that surgically invasive single-use devices for short-term use are Class IIa. This requires full involvement of a notified body for the entire product – not just the sterilisation aspect.

Class I sterile (Is): If an examination or procedure glove is supplied sterile, a sterility aspect is added. A notified body is involved specifically to certify the sterilisation process (SAL 10⁻⁶), while the device itself remains Class I.

Practical summary:

UDI – Unique Device Identification

UDI is a system for unique identification of medical devices, introduced under MDR to improve traceability and market surveillance.

UDI structure

Each medical device receives two identification levels:

• UDI-DI (Device Identifier): Identifies the specific configuration (model, size, sterile/non-sterile). Static – only changes when the product changes.
• UDI-PI (Production Identifier): Identifies the specific production (batch/lot, expiry date, serial number). Dynamic – changes per batch.

When is UDI required?

From 2025, examination gloves must carry UDI marking (UDI-DI + UDI-PI) on the packaging.

What this means for procurement

• The supplier's products must have valid UDI from 2025
• UDI-DI must be registered in EUDAMED
• Buyers should request confirmation of UDI compliance

EUDAMED – the EU medical device database

EUDAMED (European Database on Medical Devices) is the EU's central register for medical devices.

What is registered in EUDAMED?

• Manufacturers and authorised representatives
• Medical devices (UDI-DI and product information)
• Notified bodies and certificates
• Vigilance reports (incidents and recalls)
• Clinical investigations

Public access

Parts of EUDAMED are publicly accessible. Buyers can in principle search for suppliers' registrations and certificates. The database is however still under full implementation (2024–2026).

Practical relevance

As a buyer: EUDAMED allows you to verify whether a supplier's certificates are valid and notified body certificates are active. It is an additional safeguard beyond the documentation the supplier sends themselves.

Importer and distributor responsibilities (Art. 13 and 14)

MDR introduced explicit responsibilities for importers (Art. 13) and distributors (Art. 14) – not only manufacturers.

The importer (Art. 13)

An importer is any natural or legal person in the EU who places devices from a manufacturer outside the EU on the EU market.

Importer obligations:

• Verify that the manufacturer has issued a DoC and that the device is CE marked
• Verify that UDI has been assigned
• The information on the label is in the relevant national language
• Register themselves in EUDAMED as importer
• Retain documentation for a minimum of 10 years

The distributor (Art. 14)

A distributor is anyone in the supply chain who makes devices available on the market after the manufacturer's/importer's activities.

Distributor obligations:

• Verify that the product has CE marking and a valid DoC
• Check that the expiry date has not been exceeded
• Store and transport under correct conditions
• Forward complaints and incident reports to manufacturer/importer

Consequence for sales staff:

Even as a pure distributor you have responsibility. If you sell gloves without having verified CE documentation, you can be held jointly liable for any damage.

Technical documentation – what must be in place?

The manufacturer must hold and maintain technical documentation (TD) for each product. For examination gloves (Class I) this typically includes:

1. Product description: Intended purpose, classification, target group

2. Design and manufacturing information: Raw materials, manufacturing process, quality control

3. Performance requirements and testing: EN 455-1 to -5 test reports

4. Biological evaluation: ISO 10993-based assessment

5. Labelling and IFU (Instructions for Use): Conformity with MDR Annex I

6. Risk assessment: Systematic risk management (ISO 14971)

7. Clinical evaluation: Literature review or clinical data

Practical checklist for buyers

Use this checklist when evaluating a new supplier of medical examination gloves:

Basic MDR compliance:

• [ ] CE marking visible on the packaging
• [ ] Valid Declaration of Conformity (DoC) provided
• [ ] Intended purpose clearly defined (examination glove / surgical glove)
• [ ] Lot/batch number and expiry date on the packaging

Technical documentation:

• [ ] Test reports for EN 455-1 (tightness, AQL)
• [ ] Test reports for EN 455-2 (dimensions, force at break)
• [ ] Test reports for EN 455-3 (biological evaluation)
• [ ] Test report for EN 455-5 (chemical substances, accelerator status) – new!

Traceability and registration:

• [ ] Manufacturer registered in EUDAMED (verifiable)
• [ ] UDI marking (required from 2025 for Class I)
• [ ] Importer contact details (if non-EU manufacturer)

For sterile products (additional):

• [ ] Notified body certificate for sterilisation process
• [ ] Sterilisation validation documented