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  • 2017 745 - EN - Medical Device Regulation - EUR-Lex
    Regulation (EU) 2017 745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001 83 EC, Regulation (EC) No 178 2002 and Regulation (EC) No 1223 2009 and repealing Council Directives 90 385 EEC and 93 42 EEC (Text with EEA relevance
  • Medical devices | European Medicines Agency (EMA)
    The Regulations on Medical Devices (Regulation (EU) 2017 745) and on In Vitro Diagnostic Devices (Regulation (EU) 2017 746) changed the European legal framework for medical devices, introducing new responsibilities for EMA and national competent authorities in the assessment of certain categories of medical device
  • Guidance - MDCG endorsed documents and other guidance
    Regulation (EU) 2017 745 on medical devices (MDR) and Regulation (EU) 2017 746 (IVDR) on in vitro diagnostic medical devices The majority of documents on this page are endorsed by the Medical Device Coordination Group (MDCG) in accordance with Article 105 of the MDR and Article 99 of the IVDR
  • Medical Device Regulation
    Summary of references of harmonised standards published in the Official Journal – Regulation (EU) 2017 745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001 83 EC, Regulation (EC) No 178 2002 and Regulation (EC) No 1223 2009 and repealing Council Directives 90 385 EEC and 93 42 EEC
  • Medical Devices Regulation (EU) 2017 745 - MDR - DNV
    Medical Devices Regulation (EU) 2017 745 has replaced the Medical Device Directive (MDD) and the Active Implantable Medical Device Directive (AIMD), whereas the IVDR has replaced the In vitro Diagnostic Directive (IVDD) Both regulations bring a series of important improvements to conformity assessment for medical devices with the intention to:
  • Understanding Europe’s New Medical Devices Regulation (MDR 2017 745)
    (EU) 2017 745 — the Active Implantable Medical Devices Directive (AIMDD) 90 385 EEC, and the Medical Devices Directive (MDD) 93 42 EEC - do just that These directives defined ERs and introduced harmonized standards, helping to demonstrate conformity to the ERs The directives also defined conformity assessment procedures and organized
  • EU Medical Device Regulation (EU MDR) 2017-745 Quick Reference
    However, due to the global COVID-19 Pandemic, the European Commission extended the Date of Application for EU MDR by 12 months, meaning medical device companies now have until May 26, 2021, to comply with MDR requirements The Regulation is comprised of 123 Articles and 17 Annexes
  • Regulation (EU) 2017 745 of the European Parliament and of the Council . . .
    Regulation (EU) 2017 745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001 83 EC, Regulation (EC) No 178 2002 and Regulation (EC) No 1223 2009 and repealing Council Directives 90 385 EEC and 93 42 EEC (Text with EEA relevance
  • REGULATION (EU) 2017 745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL . . .
    REGUL ATION (EU) 2017 745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 Apr il 2017 on medical devices, amending Directive 2001 83 EC, Regulation (EC) No 178 2002 and Regulation (EC) No 1223 2009 and repealing Council Directives 90 385 EEC and 93 42 EEC (Text with EEA relevance)
  • EU MDR: Definition, Timelines, Requirements, and Compliance
    The European Union Medical Device Regulation (EU MDR), formally known as Regulation (EU) 2017 745 or EU MDR 2017 745, governs all medical devices within the EU Compared to the Medical Device Directive (MDD), the EU MDR introduces stricter requirements for risk management, technical documentation, clinical evaluation, post-market surveillance





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