La nouvelle régulation Européenne des dispositifs médicaux

The current EU regulation Medical Device Directive (MDD) was taken effect in 1993, and has been revised in 2010.

A. Process to obtain it [TEXT].

B. Links to resources: Link to MDD text and to the major texts

  • Directive 93/42/CEE consolidated (M5)
  • MEDDEV guidance : http://ec.europa.eu/growth/sectors/medical-devices/guidance_en
  • EU commission text on Unannounced Audits : https://eur-lex.europa.eu/legal-content/EN/ALL/?uri=uriserv:OJ.L_.2013.253.01.0027.01.ENG
  • NBOG : https://www.nbog.eu/nbog-documents/
  • NBOG codes to categorized your Medical Device : http://www.doks.nbog.eu/Doks/NBOG_BPG_2009_3.pdf
  • Kiwa Cermet codes : http://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=notification.pdf&dir_id=13&ntf_id=283473
  • National competent authority page for each language : eg in French : https://www.ansm.sante.fr/Activites/Mise-sur-le-marche-des-dispositifs-medicaux-et-dispositifs-medicaux-de-diagnostic-in-vitro-DM-DMIA-DMDIV/DM-et-DMIA-Principaux-textes-legislatifs-et-reglementaires/(offset)/3

C. Our level of requirements (guides, list of documents to be provided, etc…)

  • We don’t have much on this matter, but we could have guidelines written by some of our experts…
  • For example, the list of documents to be provided in English
    • For the ISO 13485
    • For the CE marking

D. Updates on new technology (3D manufacturing, Nanoparticles, Cybersecurity, …)[LJL2]