The Medical Devices Introductory Course 2020

Regulated as a device and conformity assessment pathway detailed in the MDR The entire device, must be assessed by a Notified Body (QMS plus technical documentation) who must seek a scientific opinion from ● European Medicines Agency (EMA) – On the quality and safety of the substance including the clinical benefit/risk profile of the incorporation of the substance into the device The Notified Body shall not deliver the certificate if the scientific opinion is unfavorable. It shall convey its final decision to EMA Manufacturer generates Declaration of Conformity  CE mark Device incorporating a human blood / plasma derivative where the action is ancillary

The Organisation for Professionals in Regulatory Affairs

Integral and non-reusable drug & device product

MDD Art.1.3 and MDR Art.1.9 Where a device is placed on the market in such a way that the device and the medicinal product are ● A single integral product ● Intended exclusively for use in the given combination ● Not reusable That single product shall be governed by Directive 2001/83/EC Example: Pre-filled syringe with a drug

The Organisation for Professionals in Regulatory Affairs