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Lexicon: M
Medical devices class I
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Medical devices class I

Class I medical devices form the lowest tier in the MDR's four-level classification system (Classes I, IIa, IIb, III). Classification is derived from the rules in Annex VIII of MDR (EU) 2017/745.

Class I products are typically non-invasive, have no contact with critical body areas, and present very low risk potential. The manufacturer may carry out the conformity assessment independently and issue the EU Declaration of Conformity without a Notified Body.

Exceptions within Class I that require Notified Body involvement:

Typical Class I products: non-sterile medical single-use gloves (EN 455), simple wound dressings, walking aids, stethoscopes.

With the MDR coming into effect (2021), requirements for Class I manufacturers were also tightened: technical documentation, clinical evaluation, and post-market surveillance are now mandatory.

Frequently asked questions

Which medical devices belong to Class I?

Class I covers non-invasive products with minimal risk, such as non-sterile medical single-use gloves (EN 455), simple wound dressings, walking aids, and corrective spectacles. Exact classification follows the rules in MDR Annex VIII.

Does a Class I product not need a Notified Body?

Not normally. Exceptions are Class Is (sterile), Class Im (measuring function), and Class Ir (reusable surgical instruments) – these require a Notified Body for the specific aspect concerned.

What changed for Class I products under MDR?

Compared to the old MDD (Directive 93/42/EEC), the MDR requires Class I manufacturers to provide comprehensive technical documentation, a clinical evaluation, a post-market surveillance system, and a PSUR. Simple self-declaration without substance is no longer sufficient.