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Great Britain and European Union Timelines: What Are the Key Dates for Transition? | McDermott Will & Emery

Published: June 3, 2023

The Medicines and Healthcare products Regulatory Agency (MHRA) recently published long-awaited guidance confirming that there will be a delay in the implementation of new legislation...

Source: jdsupra.com

Related Topics:

United KingdomUnited StatesGreat BritainRegulatory AgencyEuropean ParliamentEuropean UnionMcdermott WillMedical Devices RegulationsDevice DirectiveVitro Device DirectiveDevice RegulationExtensions GrantedMedical DeviceMedical Devices

What Does EN ISO 149712019's New Amendment Mean For Harmonisation

Published: March 4, 2022

CEN, the European standards body, recently released an amendment to the European edition of the medical device risk management standard, EN ISO...

Source: meddeviceonline.com

Related Topics:

Estonian Standardization OrganizationJournal Of The European UnionEdwin BillsOfficial JournalEuropean UnionMedical Device DirectiveActive Implantable Medical Device DirectiveVitro Device DirectiveNotified BodiesContent DeviationGeneral SafetyPerformance RequirementsRisk Management PolicyNormative RequirementsAnnexi ChapterRisk Management FileDevice Regulation