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 […]
MedTech Europe
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 […]
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 […]
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 […]
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 […]
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, […]
EU Medtech voices concerns over timing, transition to new MDR, IVDR regulations
Industry group MedTech Europe is voicing concerns over the implementation of the EU’s new Medical Devices Regulation and In Vitro Diagnostic Medical Devices Regulations, which are set to go into effect in May 2020 and May 2022. The industry group was specifically concerned about the industry’s ability to keep products on shelves after the deadlines […]
EHRA’s withdrawal forces cancellation of Cardiostim conference
Organizers of electrophysiology conference Cardiostim have cancelled the 2018 meeting after the European Heart Rhythm Association decided not to renew its 12-year running partnership with the event. The event, held every even year, claimed to gather a total of 5,740 attendees during its 2016 meeting. “In spite of the extraordinary success of the congress, and […]
Spinal Elements lifts former COO Blain to the corner office | Personnel Moves November 30, 2017
Spinal Elements, previously known as Amendia, said this week it is lifting co-founder and current prez & COO Jason Blain to the position of prez & CEO, effective immediately. Prior to coming on to co-found Spinal Elements, Blain served in various roles with medtech companies Smith & Nephew (NYSE:SNN), Alphatec (NSDQ:ATEC) and NuVasive Inc. (NSDQ:NUVA). Blain is replacing […]