Class I
Lowest risk - e.g. non-invasive devices, reusable surgical instruments. Some Class I devices (measuring, sterile, reusable surgical) need Notified Body involvement for specific aspects.
Your EU Authorised Representative & PRRC for MDR/IVDR medical devices
MDR and IVDR both use risk-based classification. Your device class affects the conformity assessment route, and we confirm classification as part of our compliance review before appointment.
Lowest risk - e.g. non-invasive devices, reusable surgical instruments. Some Class I devices (measuring, sterile, reusable surgical) need Notified Body involvement for specific aspects.
Medium-low risk - e.g. many diagnostic and short-term invasive devices.
Medium-high risk - e.g. long-term invasive devices, certain active devices.
Highest risk - e.g. implantable devices, devices incorporating a medicinal substance.
Lowest risk - e.g. general laboratory instruments and specimen receptacles.
Low-moderate individual/public health risk - e.g. most self-testing devices for general use.
High individual / moderate public health risk - e.g. tests for genetic disorders, companion diagnostics.
High individual and public health risk - e.g. blood-borne transmissible agent tests.
Combination products, devices incorporating a medicinal substance, and Annex XVI products without an intended medical purpose need an extended review before we quote representation.
Non-medical consumer products, cosmetics and general chemical products fall under separate EU regulatory regimes rather than MDR/IVDR representation.
Tell us your device type, class and where your company is established. We will qualify the next step before any mandate is signed.