Classification of Medical Devices & IVDs (EU Regulations)

“This document outlines classification criteria for medical devices (MDs) and in vitro diagnostic medical devices (IVDs) in Europe:

Medical Devices (MDs):

Classification: Based on intended use, risk level, and public health risks.

Classes:

Class I (low risk): e.g., compresses, glasses

Class IIa (medium risk): e.g., contact lenses

Class IIb (higher risk): e.g., condoms

Class III (highest risk): e.g., breast implants

In Vitro Diagnostic Devices (IVDs):

Classification: Based on intended use and risks.

Classes:

Class A (low risk): e.g., sample containers

Class B (medium risk): e.g., pregnancy tests

Class C (higher risk): e.g., companion diagnostic tests

Class D (highest risk): e.g., blood grouping devices, HIV tests

Certification Requirements:

Higher-risk classes may need notified body intervention.

Class I MDs and Class A IVDs typically don’t need intervention if non-sterile and without measuring functions.

Region: Europe

Source: https://ansm.sante.fr/documents/reference/reglementation-relative-aux-dispositifs-medicaux-dm-et-aux-dispositifs-medicaux-de-diagnostic-in-vitro-dmdiv/qualification-et-classification-des-dm-et-dmdiv