The European Union has announced that it will temporarily allow remote audits of medical devices and in vitro diagnostics under the new regulations (MDR IVDR), set to go into effect on May 2021 and 2022 respectively. In a document published Monday, the European Commission agreed with industry and notified bodies that the ongoing COVID-19 pandemic […]
EU MDR
MedTech Europe gives proposed European Health Union a partial nod
MedTech Europe has endorsed a new plan to strengthen the EU’s response to future pandemics and public health emergencies, with a few caveats. European Commission President Ursula von der Leyen outlined the plan to create a European Health Union in her state of the union speech on Nov. 11. The plan is a response to lessons learned from […]
MedTech 100 roundup: Stocks remain high after record-setting week
Medtech stocks have been on the rise since positive news regarding COVID-19 vaccines broke last week, breaking a record in the process. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — finished last week at 98.99 (Nov. 13), marking a 1.4% uptick from the 97.62 points registered at the […]
How major medtech companies are responding to the looming EU MDR
Medtech companies that sell products in the European Union have a major deadline looming — one that’s already been put off once. The EU Medical Device Regulation (MDR) will replace the current EU Medical Device Directive (MDD) on May 26, 2021. Companies whose products are approved for sale in Europe must decide if they want […]
BREAKING: EU-MDR is postponed by 1 year due to coronavirus pandemic
The European Parliament voted today to postpone implementation of its new Medical Device Regulation (MDR) by one year, giving medtech companies a welcome reprieve from their scramble to comply. EU MDR, originally scheduled to go into effect May 26, 2020, will now take effect May 26, 2021, if individual member states approve. Get the full […]
DeviceTalks Weekly: Ep. 3 – Deconstructing medtech’s alphabet soup – DPA, MDR, FDA are all in the news
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 […]
