The Medical Devices Introductory Course 2020

MDR Art.1.8, Rule 14 All devices incorporating as an integral part a substance which, if used separately, can be considered to be a medicinal product and which has action ancillary to that of the devices shall be assessed and authorized in accordance with MDR Device incorporating a drug where the action of the drug is ancillary

The Organisation for Professionals in Regulatory Affairs

Types of devices with ancillary drug

Other 15%

Vascular 24%

Woundcare 21%

Orthopaedic 15%

Latex 10%

Active Implantable 15%

The Organisation for Professionals in Regulatory Affairs