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CATÉGORIE: REGULATORY PATHWAYS

Directive sur les dispositifs médicaux (MDD)

L'ancienne directive européenne (93/42/CEE) régissant les dispositifs médicaux, remplacée par l'EU MDR. Les certificats MDD hérités ont des périodes de transition prolongées jusqu'en 2027-2028.

Last reviewed 2026-08-05 · Reviewed by MedFlux Editorial Board · Editorial policy

Expanded process notes below are currently maintained in English; the short definition above is localized. See our editorial policy.

WHEN IT APPLIES

MDD (93/42/EEC) was the prior EU medical device directive, replaced by EU MDR. Legacy certificates may still be in transition depending on class and timelines.

PROCESS / STEPS

  1. Confirm whether any portfolio still relies on MDD certificates.
  2. Map each device to MDR class and NB capacity.
  3. Plan technical documentation uplift (clinical, PMS, UDI).
  4. Track certificate expiry and progressive rollout obligations.

EXAMPLES

  • A Class IIb device may still operate under an extended MDD certificate while preparing MDR technical docs.

RELATED GUIDES & TOOLS

SOURCES

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TERMES CONNEXES

EU MDR (Règlement 2017/745)Marquage CEOrganisme notifié