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Medical Device Makers Ending Production of Life-Saving Devices Due to New EU Law

A recently passed law by the European Commission (EC), meant to improve safety standards for medical devices in .

Region flamandeBruxelles capitaleStella kyriakidesMarc gewilligMikael johanssonJohn odeaEuropean councilEu healthUniversity hospital leuvenEuropean union medical devices regulationEuropean parliamentEu commissionEuropean commissionDrug administrationStanding committee of european doctorsEuropean union

EU Council Support Proposed MDR Transitional Deadline Delay

Highlighted concerns included thousands of outstanding conformity assessments and fear of widespread shortages.

Bruxelles capitaleStella kyiakidesEuropean union medical devices regulationConsumer councilEuropean unionMedical devices regulationSocial policyVitro diagnostic devices regulation

PHC Corporation: PHC Receives First EU-MDR Certification, Delivers Motorized Drug Injection Device Enabling More Efficient Patient-Friendly Treatment of Arthritis and Other Inflammatory Conditions

The In Vitro Diagnostics Division of PHC Corporation (hereafter, PHC IVD), a provider of medical devices and diagnostics, today announced that it has received European Union Medical Devices Regulation

United statesHiroyuki tokunagaHiroko araiBluetooth sig incEuropean union medical devices regulationHoldings corporationEuropean commissionVitro diagnostics divisionInvestor relations corporate communications departmentD product service gmbMedical devices directiveActive implantable medical devices directiveSouth americaVitro diagnosticsRelations corporate communications department

Japan s PHC receives first EU-MDR certification

Japan's PHC receives first EU-MDR certification

United statesEuropean union medical devices regulationVitro diagnostics divisionSouth americaPortable device

Esaote Obtains EC MDR Certification for the New Magnifico Open Total-body Magnetic Resonance System

The new European Union Medical Devices Regulation (MDR), Regulation (EU) 2017/745, came into force on May 26, 2021

Massimo polignanoEuropean union medical devices regulationEuropean parliamentMagnifico openNotified bodiesEsaote magnifico openQuality management systems

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