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como novedad incluye …

  • Segunda Corrigenda de los Reglamentos de productos sanitarios
  • Documentos adoptados por el MDCG
    • MDCG 2019-6v2 Questions and answers: Requirements relating to notify bodies
    • MDCG 2019-10 Application of transitional provisions concerning validity of certificates issued in accordance to the directives
    • MDCG 2019-12 Designating authority’s final assessment form: Key information (EN)
    • MDCG 2019-13 Guidance on sampling of devices for the assessment of the technical documentation
    • MDCG 2019-14 Explanatory note on MDR codes
    • MDCG 2019-11 Qualification and classification of software – Regulation (EU) 2017/745 and Regulation (EU) 2017/746
    • MDCG 2019-16 Guidance on cybersecurity for medical devices
    • MDCG 2019-15 Guidance notes for manufacturers of class I medical devices
  • Información sobre el desarrollo de la base de datos europea de productos sanitarios EUDAMED
  • Vigilancia de Productos Sanitarios