The Medical Devices Introductory Course 2020

Legal Basis for Classification MDR Article 1(9)

If the device intended to administer a medicinal product and the medicinal product are placed on the market in such a way that they form a single integral product which is intended exclusively for use in the given combination and which is not reusable, that single integral product shall be governed by Directive 2001/83/EC or Regulation (EC) No 726/2004 , as applicable. In that case, the relevant general safety and performance requirements set out in Annex I to this Regulation (MDR) shall apply as far as the safety and performance of the device part of the single integral product are concerned.

The Organisation for Professionals in Regulatory Affairs

Classification where a drug and device are combined in a single product

As a Medical Device The product must meet the definition as a medical device per MDR (EU) 2017/745 The drug must act in an ancillary way to the device The “device” cannot be merely a means of delivering a drug

As a Medicinal Product The product must meet the definition as a Medicinal Product as 2001/83/EEC Device acts in an ancillary way to the Drug

Drug and Device form a single integral product and intended exclusively for use in the given combination and which is not reusable

The Organisation for Professionals in Regulatory Affairs