The Medical Devices Introductory Course 2020

Classification of medical devices Classification Criteria

MDD, Annex IX, MDR Annex VIII Duration of contact: ● Transient, Short term, Long term Degree of invasiveness: ● Implantable, Surgical, Body orifice

Anatomy affected Active / Non-active

The Organisation for Professionals in Regulatory Affairs

Classification of medical devices Classification Criteria

Duration of Contact Transient:

< 60 minutes

Short term: Long term:

60 minutes ≤ 30 days

> 30 days

Immediate replacement by similar device is a continuation of original use

The Organisation for Professionals in Regulatory Affairs