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類別: REGULATORY PATHWAYS
醫療器材指令(MDD)
前歐盟醫療器材指令（93/42/EEC），現已被EU MDR取代。MDD舊證書根據器材分類有延長至2027-2028年的過渡期。
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
- Confirm whether any portfolio still relies on MDD certificates.
- Map each device to MDR class and NB capacity.
- Plan technical documentation uplift (clinical, PMS, UDI).
- 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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