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 :
  • EU commission text on Unannounced Audits :
  • NBOG :
  • NBOG codes to categorized your Medical Device :
  • Kiwa Cermet codes :
  • National competent authority page for each language : eg in French :

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]