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EU IVDR

MedTech Europe warns on ongoing regulatory issues

May 26, 2021 By Nancy Crotti

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 […]

Filed Under: Business/Financial News, Diagnostics, Regulatory/Compliance Tagged With: EU IVDR, EU MDR, MedTech Europe

EU allows remote audits for medical devices during pandemic

January 12, 2021 By Nancy Crotti

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 […]

Filed Under: Business/Financial News, Diagnostics, Featured, Regulatory/Compliance Tagged With: bsi, EU IVDR, EU MDR, European Commission, European Union, MedTech Europe

MedTech Europe gives proposed European Health Union a partial nod

November 20, 2020 By Nancy Crotti

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 […]

Filed Under: Business/Financial News, Clinical Trials, Diagnostics, Featured, Regulatory/Compliance Tagged With: coronavirus, COVID-19, EU IVDR, EU MDR, European Commission, European Union, MedTech Europe

MedTech Europe wants halt of EU MDR implementation amid coronavirus crisis

March 23, 2020 By Sean Whooley

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 […]

Filed Under: Featured, Regulatory/Compliance Tagged With: coronavirus, COVID-19, EU IVDR, EU MDR, MedTech Europe

MedTech Europe slams EU over lack of preparation for MDR/IVDR

November 26, 2019 By Nancy Crotti

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 […]

Filed Under: Diagnostics, Featured, Regulatory/Compliance Tagged With: EU IVDR, EU MDR, MedTech Europe, Oriel Stat A Matrix

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