In the context of the anticipated targeted assessment of the Medical Devices and In Vitro Diagnostics Regulations (MDR & IVDR), the MPP Association shared a letter with the European Commission to present MPP priorities. This letter presents key aspects on which our members would welcome solutions as part of the expected evaluation.
One of the most significant challenges highlighted in this letter concerns combined products using medical device technology platform, such as syringes injection pens, autoinjectors and inhalers. Those medical device technology platforms often rely on well-known legacy products. Although the same medical device technology platform is used in multiple combined products, this device part is nevertheless subject to repeated reviews under MDR Art. 117, leading to multiple applications.
The MPP Association also draws attention to other challenges currently faced by MPP members in relation to the MDR compliance, which concern scientific advice; the alignment of advice across regulators and Notified Bodies when assessing aspects like the summary of product characteristics (SmPC) and the package leaflet (PL) of co-packaged combined products; the lifecycle management of combined products; the repackaging/relabelling of medical devices; and post-market requirements for co-packaged medical devices.
Read the full letter and discover proposed solutions formulated by the MPP Association here.
