Knowledge · EU MDR classification
Classification under EU MDR: class I to III
22 rules in Annex VIII classify every medical device — the basis of the entire conformity route.
Classification under EU MDR assigns every medical device to classes I, Is, Im, Ir, IIa, IIb or III based on 22 rules (Annex VIII). Duration of use, invasiveness, active principle and site of application are decisive. The class determines the conformity assessment route — and whether a notified body must be involved.
The classes at a glance
| Class | Examples | Procedure |
|---|---|---|
| I | Plasters, examination gloves, textile bandages | Self-declaration (except Is/Im/Ir) |
| IIa | Nasal sprays, vaginal gels, oral/throat sprays | Notified body (audit) |
| IIb | Antireflux products, many intimate health devices, sterile wound care | Notified body (extended procedure) |
| III | High-risk products such as implants and devices protecting against transmissible diseases | Notified body (design dossier) |
How the rules apply
Rules 1–22 are checked in order; the first matching rule determines the class. In case of doubt the higher class applies in favour of safety (rule 3). Example: rule 21 covers substances applied at or via a body orifice (nose, mouth, vagina, rectum) — typically class IIa/IIb.
Consequences of the class
- Class I: manufacturer’s own declaration of conformity, EUDAMED registration.
- IIa/IIb/III: the notified body audits QM and technical documentation and issues the MDR certificate.
- Higher class = more effort in documentation, clinical evaluation and certificate lifetime.
Frequently asked questions
Who determines the class?
The manufacturer — with justification in the technical documentation. INOPREX performs the classification with justification upfront.
Why does class III exist?
For products with a particularly high risk — such as implants or devices protecting against transmissible diseases. They undergo the strictest conformity assessment with a design dossier at a notified body.
Applied to your project
We apply these rules directly to your project — from classification to market access. First assessment within two working days.