How To Navigate Clinical Data Per EU MDR
By Matthias Fink, MD, TÜV SÜD America
In May 2017, the European Medical Devices Regulation (MDR) 2017/745 was published to replace the current Medical Device Directive (MDD) and the Active Implantable Medical Device Directive (AIMDD). In April 2020, the European Parliament adopted the European Commission’s proposal to postpone the Date of Application (DoA) of the MDR by one year, and as such, the new DoA is May 26, 2021. It is worth noting that the end of the transition period for MDD and AIMDD certificates remains May 26, 2024, thus reducing the timeline for manufacturers to get their MDR certificates from four to three years.
Prodways Group 3D Materials division recorded major successes in the field of Medical applications
Prodways Group 3D Materials division recorded major successes in the field of Medical applications
Prodways Group (Euronext Paris : PWG), specialist in digital design and manufacturing, announces major successes in the field of medical applications for its 3D Materials division.
In the continuity of a very successful year 2020 and despite the Covid-19 crisis, Prodways Group s materials division, DeltaMed, recorded outstanding successes in its dental products division by i/ signing an agreement with a leading global player in the dental industry, ii/ successfully implementing new regulatory requirements, iii/ with a solid order backlogs for 2021, in particular multi-tons of resins to support fast growing clients in the aligner market.