The Medical Devices Introductory Course 2020

Example IVD Label

GTIN

Pregnancy Test

2019-12- 25 0123456 ABC1234

0123

3

28°C

Red Circle Projects International Ltd 123 Camber Drive Chicago USA

GTIN XXXXXXXXXXXXXX LOT XXXXXXX EXPIRYXX/XXXX

-2°C

Red Circle Projects GmbH Friedrich Str.

Red Circle Projects GmbH Friedrich Str.

Munich, Germany www.redcircle.com

Munich, Germany info@redcircle.com www.redcircle.com

L001 v1

ISO15223 Series - Use of symbols

The Organisation for Professionals in Regulatory Affairs

• IVDs are critical to the diagnostic pathway and have been since the 70’s • IVD’s are regulated in the EU in a similar but not the same way as medical devices • New Regulation brings major change for IVDs • Oversight by Notified Bodies will increase • Classification completely changes • New Product Groups • Focus on Performance rather than Clinical elements Summary

The Organisation for Professionals in Regulatory Affairs