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KATEGORIE: CLASSIFICATION

Kombinationsprodukt

Ein Produkt, das ein Medizinprodukt mit einem Arzneimittel, Biologikum oder beidem kombiniert.

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

Combination products combine drug/device, biologic/device, or drug/biologic constituents (e.g., prefilled syringes, drug-eluting stents). Jurisdiction and primary mode of action determine lead center and submission type.

PROCESS / STEPS

  1. Request designation/RFD when primary mode of action is unclear.
  2. Map constituent requirements (cGMP for drugs, QSR/QMSR for devices, etc.).
  3. Plan integrated clinical and CMC/device performance evidence.
  4. Align labeling, postmarket reporting, and change control across constituents.

EXAMPLES

  • An autoinjector with a biologic is typically a combination product with CDER/CBER lead depending on PMOA.

RELATED GUIDES & TOOLS

SOURCES

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VERWANDTE BEGRIFFE

Premarket Approval (PMA)EU MDR (Verordnung 2017/745)