The Medical Devices Introductory Course 2020

MDR Rules 1 - 4

Rule 1: No change Rule 2: Now includes “cells” & clarification that blood bags are class IIb (Blood bags moved to MDR Rule 2 from Rule 18 of MDD) Rule 3: also includes: All non-invasive devices consisting of a substance or a mixture of substances intended to be used in vitro in direct contact with human cells, tissues or organs taken from the human body or used in vitro with human embryos before their implantation or administration into the body are classified as class III. (Inclusion of organ storage solutions, IVF media into the rule which are class III) Rule 4: also includes “mucous membrane”, Replacement of ‘wounds’ with injuries to skin & applies also to invasive devices that come into contact with injured mucous membrane.

The Organisation for Professionals in Regulatory Affairs

Rule 8: (Up-classification of surgical meshes and spinal devices to Class III) Additional indents: • Active implantable devices or their accessories: Class III • Breast implants or surgical meshes: Class III • Total or partial joint replacements : Class III except for ancillary components such as screws, wedges, plates and instruments • Spinal disc replacement implants or implantable devices that come into contact with spinal column: Class III except for components such as screws, wedges, plates and instruments MDR – Surgical meshes and spinal devices Rule 8

The Organisation for Professionals in Regulatory Affairs