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Form 10-K Nuvalent, Inc For: Dec 31

Form 10-K Nuvalent, Inc For: Dec 31
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Boston collegeUnited statesUnited kingdomNew mexicoDuke universityNorth carolinaCollege of the holy crossNew hampshireNorthern irelandDana farber cancer instituteHarvard universityUniversity of massachusettsGreat britainAlexandra balcomJamesr porterDeborah miller

The European Parliament Votes In Favor Of Amending The Transitional Provisions In The MDR And The IVDR - Product Liability & Safety

The European Parliament approves the European Commission's proposal to extend the transitional periods in the MDR and remove the "sell-off" deadline in the MDR and IVDR.

European parliamentEuropean commissionCouncil of the europeanCouncil onConsumer affairs councilEuropean unionUnion councilPermanent representatives committeeMedical devices directiveActive implantable devicesVitro medicalDevices directiveCooley alertOfficial journalThe european parliament votes in favor of amending transitional provisions mdr and ivdrConsumer protection

Form 10-K INTEGRA LIFESCIENCES For: Dec 31

Form 10-K INTEGRA LIFESCIENCES For: Dec 31
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United statesCity ofUnited kingdomUnited arab emiratesSaint aubin le monialNew zealandMonte carloCoahuila de zaragozaNew yorkFlorham parkNew jerseyRietheim weilheimBaden wübergPuerto ricoStuartm essigIntegra lifesciences

European IVD Makers Continued to Face Regulatory Uncertainty Around IVDR, Brexit in 2022

A shortage of regulatory capacity continues to slow the implementation of the EU's In Vitro Diagnostic Regulation.

United kingdomNorthern irelandNoord hollandErik vollebregtPeter biedermannAnita tollerStephen leeRichard houlihanKec internationalEu medical device coordination groupEuropean commissionDrug administrationSwiss federal assemblySwiss federal councilUnited kingdom office for life sciencesHealthcare products regulatory agency

The EU IVDR Is Here! - Healthcare - United States

As of today, the 26 May 2022, the in vitro diagnostic Medical Devices Regulation (EU 2017/746) (IVDR) applies across the EU.

United kingdomNorthern irelandGreat britainLab developed tests ldtsDevice coordination groupEuropean medicines agencyMedical devicesDevices directiveNotified bodiesMedical device coordination groupNotified bodyInformation systemDeveloped testsSwitzerland mutual recognition agreementMedical deviceLife sciences