With the implementation of the MDR, the Marketing authorization holder (MAH) must also show compliance for the device part of the combination product with the applicable GSPRs as outlined in Annex I. acc. Article 117. During this presentation we will highlight the differences for you as a manufacturer between the approach for a CE-marked medical device and the Notified Body Opinion for an Article 117 device. We will focus on general obligations for the manufacturer, as well as on biocompatibility and sterility aspects.
This presentation was recorded on March 24 and is part of a series.