Exciting new data for the next-generation Dexcom (NSDQ:DXCM) G7 continuous glucose monitor (CGM) surprised even the company’s leadership. Dexcom Chair, President & CEO Kevin Sayer — presenting clinical study results for the G7 at the 40th Annual J.P. Morgan Healthcare Conference — has previously lauded the expected impact of the wearable glucose monitor, and the new data […]
EU MDR
MedTech 100 roundup: On the rise again
Last week provided a glimmer of light for medtech after a rough few weeks as the industry continues to push in the right direction. MassDevice‘s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — finished the week (May 28) at 108.5 points, producing a 0.7% rise from the 107.74-point mark […]
MedTech Europe warns on ongoing regulatory issues
MedTech Europe welcomed the first wave of new E.U. medical device regulations this week, but said there’s work that’s yet to be done. The trade group noted that EU MDR — the new regulatory regime for medical devices — strengthens the system of notified bodies, or companies that conduct audits on each device whose manufacturer […]
EU MDR finally goes into effect
The E.U.’s Medical Device Regulation (MDR) takes effect tomorrow, changing the process to gain entry to the continental market. EU MDR replaces the EU Medical Device Directive (MDD) with more stringent requirements on the companies that perform the audits for each device, also known as notified bodies. The change affects not only devices that are […]
EU allows remote audits for medical devices during pandemic
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 […]
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 […]
