In this week’s DeviceTalks Weekly, we’ll examine how governmental effort, both foreign and domestic, are hitting the medtech industry. Our guests include Tracy Eberly, CEO of Fang Consulting, a regulatory advisory group. Eberly will update listeners on what pushing back the MDR deadline could mean for medtech companies and why some companies may be less […]
European Commission to ask for EU MDR enforcement delay
The European Commission is putting together a proposal to ask the European Parliament and Council to delay enforcement of the new Medical Device Regulation (EU MDR) by one year in light of the coronavirus pandemic. Medical device companies have been scrambling to meet the implementation of the new MDR, scheduled for May 26. (The in […]
MedTech Europe wants halt of EU MDR implementation amid coronavirus crisis
Trade association MedTech Europe announced today that it is calling on EU institutions to postpone the implementation of the new Medical Devices Regulation and In Vitro Diagnostics Regulation (IVDR) amid the outbreak of COVID-19. Medical device companies have been scrambling to meet the implementation of the new MDR and IVDR. May 26 has been a […]
10 medical device industry stories you need to know
From leadership changes to tax repeal to robots — lots of robots — this was a busy year for the medical device industry. Here are 10 stories in the medtech space that especially caught the eye of MassDevice and Medical Design & Outsourcing editors and readers in 2019. Next>>
MedTech Europe slams EU over lack of preparation for MDR/IVDR
With six months to go before the EU’s new Medical Device Regulation takes effect, Europe’s medtech trade association is accusing government authorities of dragging their feet on the process. MedTech Europe said that the industry is trying to prepare but that it remains “seriously held back by the slow and piecemeal implementation” of the new […]
Report: Most medical device makers not ready to meet E.U. MDR deadline
Only about a fourth of medical device companies plan to be fully compliant with the European Union’s new Medical Device Regulation when it goes into effect on May 26, 2020, according to a new survey from the Regulatory Affairs Professionals Society (RAPS) and KPMG. The survey — which closed in late June and was released […]
Biotronik first to land MDR certification for a high-risk device
Biotronik said today that it is the first medtech manufacturer to receive European Medical Device Regulation (MDR) certification for a Class III (highest risk) medical device. Following a conformity assessment, Biotronik also obtained MDR certification for its quality management system, the Berlin, Germany-based company said. Get the full story on our sister site, Medical Design & […]
