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 […]
European Commission
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 […]
European Commission scrutinizes J&J TachoSil buy
The European Commission said Wednesday that it has opened an in-depth investigation of the proposed $400 million acquisition of Takeda Pharmaceutical’s (TSE:4502;NYSE:TAK) TachoSil surgical sealant patch by Johnson & Johnson (NYSE:JNJ). The commission said it is concerned that the acquisition by J&J’s Ethicon unit may reduce competition and innovation for the supply of dual haemostatic patches, used […]
European Commission to ask for EU MDR enforcement delay
The European Commission is putting together a proposal to ask the European Parliament and Council to delay enforcement of the new Medical Device Regulation (EU MDR) by one year in light of the coronavirus pandemic. Medical device companies have been scrambling to meet the implementation of the new MDR, scheduled for May 26. (The in […]
European Commission moves to protect personal protective equipment availability during COVID-19
The European Commission this week said it has taken immediate steps to protect the availability of supplies of personal protective equipment in the wake of COVID-19. The Commission is requiring that exports of such equipment outside of the European Union to be subjected to an export authorization by member states. “The challenges presented by the […]
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, […]
Canon plunges on $3B EU fine threat over Toshiba Medical deal
(Reuters) — Canon (NYSE:CAJ) shares fell to their lowest levels in more than two months today after European regulators said they may fine it up to 10% of annual revenue for jumping the gun in its acquisition of Toshiba’s (TYO:6502) medical unit. The European Union Commission said it had reached a preliminary view that Canon breached rules […]
Clock starts on tightened EU medical device regulations
The clock started ticking today on tighter new regulations for the medical device and in vitro diagnostic industries in Europe when the European Commission published the new rules. The regulations, approved last month by the European Parliament, include stronger post-market surveillance rules and adding a safety check for high-risk devices. The new EU rules, which also mandate […]
European anti-trust regulators grant conditional approval for Abbott’s $25B St. Jude Medical buy
Anti-trust regulators in the European Union last week granted conditional approval for the $25 billion merger of Abbott (NYSE:ABT) and St. Jude Medical (NYSE:STJ). The European Commission’s decision on the deal requires the divestiture of a pair of device lines: St. Jude must deal its Angio-Seal and Femoseal vascular closure assets, including a manufacturing plant in Puerto Rico, and […]
Report: EU regulators poised to OK Abbott’s $25B St. Jude Medical acquisition
Antitrust regulators in the European Union are reportedly poised to give conditional clearance to the $25 billion merger of Abbott (NYSE:ABT) and St. Jude Medical (NYSE:STJ). The European Commission has until next week to make its decision on the deal, after the companies earlier this month made concessions designed to assuage the commission’s monopoly fears. Abbott and St. Jude agreed last […]