Inspire Medical Systems announced today that its Inspire therapy has secured its CE mark under the EU’s Medical Device Regulation. Going into effect in 2021, the tighter regulations in the European Union have been a major challenge for medical device companies. With worries growing that medtech companies would pull products out of the EU because […]
EU MDR
Getinge wins European approval for covered stent system
Getinge announced today that it received EU MDR certification for its Advanta V12 covered stent system for patients with aortoiliac occlusive disease (AIOD). The balloon-expandable covered stent’s indication aligns with AIOD, which includes treating lesions at the aortic bifurcation. Getinge said EU MDR certification highlights its dedication to providing safe, effective, high-quality products. With the […]
Butterfly Network wins CE mark for IQ+ handheld ultrasound tech, hopes for next-gen nod this year
Butterfly Network (NYSE:BFLY) announced today that it garnered CE mark approval for its Butterfly iQ+ ultrasound system. The company obtained European Union Medical Device Regulation (EU MDR) certification for the iQ+ system. It initially received CE mark in 2021, but had to fall in line with updated, more stringent regulations in Europe. According to a […]
MDR reportedly causing medtech companies to leave EU market
The EU’s new Medical Devices Regulation (MDR) has created enough compliance costs that some medtech companies have stopped selling there., according to a report from Reuters. Reuters spoke with eight companies, including the Swedish medtech giant Getinge, who are either withdrawing from the EU market or have stopped making medical devices. The costs of complying […]
The top 10 medtech regulatory stories of 2022
There was plenty of news from the FDA, but the medtech regulatory story that got the most attention from MassDevice readers was out of Europe. Here are the top medtech regulatory stories on MassDevice and Medical Design & Outsourcing in 2022: 10. Philips’ respiratory devices recall has even more problems It’s one of the most […]
European Commission proposes EU MDR deadline delay until 2028
The European Union’s Health Commissioner today proposed pushing back the deadline for its new medical device regulation (MDR) law. Reuters first reported the news yesterday and confirmed it today. Commissioner Stella Kyriakides proposed a delay for the deadline for companies to comply from 2024 to as late as 2028. According to the report, this comes […]
Dexcom CEO touts unprecedented performance of G7 in clinical trial, awaits FDA decision
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 […]
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 […]
