Description: MDR Article 117 amends the medicinal products Directive 2001/83/EC and therefore the requirements for manufacturers of drug/device combinations applying for Market Authorisation Applications. This new requirement ensures the device part is reviewed by a Notified Body (NB) whereas the medicinal part will continue to be reviewed by the Competent Authorities; it is noted there is potential for overlap between these reviews. As new guidance on this area becomes available and the NB gains experience with Article 117 reviews, this presentation will explain the process from start to delivery of a Notified Body Opinion (NBOp). This will include a summary of drug/device combinations and the routes to conformity depending on category; the documentation required by the NB and areas of assessment. A description of the NB assessment process and output will also be covered. The presentation will give guidance on deciding the ‘relevant’ General Safety and Performance requirements including sterility, stability and labelling. It will also aim to discuss changes to drug/device combinations that may trigger a new NBOp.
Upon completion of this session, participants should be able to understand the requirements of Article 117 as it applies to new drug/device combination marketing applications
Upon completion of this session, participants should be able to understand submission requirements to facilitate Notified Body review and the latest guidance with respect to Notified Body Opinions.