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 […]
EU MDR
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 […]
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 […]
