The Medical Devices Introductory Course 2020

Device incorporating a drug where the action of the drug is ancillary

Regulated as a device and conformity assessment pathway detailed in the MDR Conformity assessment involves the examination of the technical documentation and device design and production coupled with the QMS Assessment by a Notified Body with designated scope The Notified Body will verify the usefulness of the medicinal substance as part of the medical device and seek a scientific opinion, from ● One of the EU medicinal product competent authorities or EMA on the quality and safety of the substance including the clinical benefit/risk profile of 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 the medicinal products competent authority concerned or to the EMA Manufacturer generates Declaration of Conformity  CE mark

The Organisation for Professionals in Regulatory Affairs

MDR Art. 1.8 All devices incorporating as an integral part a substance which, if used separately, can be considered to be a medicinal product derived from human plasma and with action ancillary to that of the devices, shall be assessed and authorized in accordance with MDR Device incorporating a human blood / plasma derivative where the action is ancillary

The Organisation for Professionals in Regulatory Affairs