Borderline product guidance is primarily in MDCG 2022-5. Drug-device combinations are addressed in MDR Art. 1(8)–(9), MDR Annex I §12.2, and relevant EMA guidance. ATMP combination products are governed by Regulation (EC) No 1394/2007.
Regulatory basis - MDR = Regulation (EU) 2017/745 | IVDR = Regulation (EU) 2017/746. Both regulations are mutually exclusive — a product is governed by one or the other, never both simultaneously.
Regulatory basis - Exclusions from the MDR are set out primarily in Article 1(5) and 1(6) of Regulation (EU) 2017/745. Equivalent IVDR exclusions appear in Article 1(4) and 1(5) of Regulation (EU) 2017/746.