EMA’s draft guideline on quality requirements for drug-device combination (DDC) products provides a template for the new concept of the notified body opinion (NBOp), intended to help ensure a consistent interpretation by individual assessors, notified bodies, and industry.
As part of the effort to standardize expectations for combination products in the EU, the draft DDC guideline was released at the beginning of June for a 90-day consultation period ending August 31. The goal is for the comments to be collated and reviewed and the final guideline released by early next year, in advance of the implementation of the new EU medical device regulations in May 2020 (see IPQ November 26, 2017).
In presentations at conferences and workshops over the last year, the evolution of the EMA guideline has been shared openly by regulators in the effort to garner industry input ahead of the formal consultation period.
EMA’s joint Quality and Biological Working Party (QWP/BWP) engagement activities have also extended to direct discussions with notified bodies (NBs), the accredited third-party entities responsible for approving CE marking of higher risk medical devices in Europe. Reflective of these discussions, the template included in the guideline outlines the information that medicine assessors would find helpful from the NB device reviewers.
At the CASSS EU CMC forum held in Seville, Spain in mid-May, the co-rapporteur for the guideline, HPRA Executive Pharmaceutical Assessor Nick Lee, highlighted its key concepts and structure, explaining the interaction with notified bodies, the new NBOp, and requirements for integral versus non-integral DDCs.
Lee also explained the background thinking on key topics including: ● platform technologies ● quality aspects of bridging to pivotal clinical trials ● lifecycle management, and ● emerging technologies.
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