Pfizer and BioNTech announced today that European authorities approved storage of their COVID-19 vaccine at a new temperature. Based on data showing stability in standard pharmaceutical freezers, the European Medicines Agency (EMA) approved storage of the vaccine at -25°C to -15°C for a total of two weeks. The FDA’s requirements include two-week storage at the same temperatures, […]
European Union
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 […]
EU science chief resigns over government response to coronavirus
Disappointed in the European Union’s response to the coronavirus pandemic, the head of its top science organization has resigned. Mauro Ferrari was president of the European Research Council (ERC) since Jan. 1. His resignation was effective immediately, according to the council. Ferrari claimed he had run into institutional and political roadblocks when he tried to […]
Europe waives tariffs, import taxes on COVID-19 medtech
The European Commission has decided to waive tariffs and value-added taxes (VAT) on certain medical devices and personal protective equipment (PPE) coming from outside the EU during the coronavirus pandemic. The measure includes testing kits, ventilators and other medical equipment and will remain in force for six months, the commission said today. Get the full […]
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 […]
Acorda’s Parkinson’s device moves closer to E.U. approval
Acorda Therapeutics (NSDQ:ACOR) said today that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended approval of its Inbrija device for the intermittent treatment of “off” episodes in people with Parkinson’s disease. The self-administered, inhaled therapy is designed for people experiencing a re-emergence of Parkinson’s symptoms. These “off” episodes are caused by low […]
MedTech Europe warns of device flight to U.S. and China if MDR not ready
Europe’s medical device trade group is again warning the European Commission that its new Medical Device Regulation (MDR) system will not be ready by its 2020 deadline and that E.U. medtech companies are taking their business elsewhere as a result. In an open letter to Jyrki Katainen, the commission’s vice president for jobs, growth, investment and competitiveness, […]
7 medtech ideas out of Europe
Mobile and digital health ideas — and overall medtech innovation ideas — abound in Europe, with DeviceTalks Boston attendees getting just a sampling this morning from seven CRAASH Barcelona participants. The CRAASH Barcelona program trains research projects on how to market their health technologies during a three- to five-year period. It’s a boot camp run by EIT Health, the main European healthcare consortium, […]
Europe’s new MDR: Is it as scary as you might think?
The European Union’s regulation of medical device appears to be increasing under the new Medical Device Regulation (MDR) going into effect, while U.S. FDA is easing off. In many ways, the E.U. and the U.S. are going in opposite directions when it comes to medical device regulation, said Michael Drues, a regulatory consultant based outside […]
Report slams European Union’s high-risk medical device approvals rate
A health economics and outcomes research group has concluded that the assessment for high-risk medical devices in the European Union is of low quality and needs improvement. The report appears in the December 2017 issue of Value in Health by ISPOR. Get the full story on our sister site Medical Design & Outsourcing.
