The event saw key figures speak from the industry including policy makers.
James Stern, president of MPPE, updated those attending on the association’s 2018 activities and the outlooked for 2019.
He said: “Next year, our Regulatory Taskforce will be more active than ever. Our priorities are to engage with the MDR authorities via the Medical Device Coordination Group and bilateral meetings with the European Commission. Other major issues to work on will be European (and US) Pharmacopoeia and possible regulation on nanomaterials.”
MPPE will present a scanning tool for its members to assess regulations of substances included MDR.
MPPE member Anja Gottschalk, application development engineer healthcare at Borealis, presented the view of material suppliers on the VDI 2017 Medical-Grade Plastics Guidelines. Mark Lloyd Davies, J&J presented the status of the Brexit negotiations and the actions Johnson & Johnson have undertaken to prepare for the different possible scenarios, and the effect it may have on the medical plastics industry.
Three presentations were dedicated to the upcoming Medical Device Regulation. First, Françoise Schlemmer, director of Team-NB presented the notified body perspective of the implementation of the new regulations. Afterwards, Salvatore Scalzo, DG Grow, gave an in-depth update from the European Commission on MDR, IVDR and the Future EU UDI System. Christian Pommereau, principal engineer at Sanofi provided the view from the industry. He stressed the fact that the changes brought by the MDR are extremely difficult to manage but associations can help to tackle the issues together as an industry.
Source : medicalplasticsnews.com