Drug device combinations (DDC) where the medicinal product incorporates a medical device in an integral manner will be subject to Art. 117 of the MDR which stipulates that a MAA for an integral DDC shall include evidence of the conformity of the device part with the relevant General Safety and Performance Requirements (GSPR). If the device component is not CE marked, and a Declaration of Conformity is not available, a Notified Body (NB) opinion on the conformity of the device with the relevant GSPRs is required to be submitted with the MAA.
Obtaining a NB opinion prior to submission of the MAA requires a sea-change in the way of preparing MAA dossiers for DDC products. For pharma companies that to-date had no interaction with a NB, the implementation of MDR requires the selection and relationship-building with a NB and a determination of the outline, scope, and level of detail necessary for the device technical documentation in support of the opinion request to ensure a rapid and efficient review by the NB in order not to delay the MAA timeline.
The CMC SPIN would like to know if there is interest from the CMC community for a webinar to review the NBs expectations and the process to timely obtain a NB Opinion. The webinar will focus on Timeline, Requirements and Impact on the MAA Process, industry experience so far, and EMA key messages.
Please share your questions below so that we can provide answers at the webinar.
Timing of the webinar, in case of sufficient interest, will be communicated soon.
We appreciate your feedback.
CMC SPIN Steering Group.