The Medical Devices Introductory Course 2020

Scope of Article 117

Within Scope Medicinal products that form an integral product with a medical device, where the action of the medicinal product is principal

Excluded from Scope

Combined ATMPs – Regulation 1394/2007

•

• Non-Integral Combinations • Co-packaged devices with medicinal products • Cross-labelled products

Reference: Second subparagraph Article 1(8) and Article 1(9), MDR (EU) 2017/745

The Organisation for Professionals in Regulatory Affairs

Case Studies

The Organisation for Professionals in Regulatory Affairs