Active medical devices
MDR Annex VIII, Rules 9–13 and Rule 22 govern active device classification. MDR Annex I, GSPR §14–16 and §19–22 cover design requirements for active and energy-emitting devices.
Software as a Medical Device (SaMD)
MDR Art. 2(1) (software included in definition); MDR Annex VIII Rule 11 (classification); MDR Annex I §17 and §21 (GSPR for software). MDCG 2019-11 and MDCG 2021-24 provide detailed guidance. For IVD software: IVDR Annex VIII Rules 1–7.
Implantable devices & implant card
MDR Art. 2(5) (definition); MDR Annex VIII Rule 8 (classification); MDR Art. 18 and Annex XV §2.12 (implant card); MDR Annex I §22–23 (GSPR for implantables). Active implantable devices are governed by the same regulation (AIMDs are now Class III under MDR).
Devices incorporating a medicinal substance
MDR Annex VIII Rule 14 (classification); MDR Art. 1(8)–(9) (drug-device combination products); MDR Annex I §8 (GSPR). Integral drug-device combinations where the device action is principal are Class III under MDR and require EMA or NCA consultation.
Devices with human/animal tissues
MDR Annex VIII Rules 17–18 (classification); MDR Annex I §13 (GSPR); EN ISO 22442 series (animal tissue requirements); European Pharmacopoeia Chapter 5.2.8 (TSE risk minimisation). Devices made from non-viable human tissue are Class III; non-viable animal tissue devices are also Class III (with some Class IIb exceptions).
Custom-made devices
MDR Art. 2(3) (definition); MDR Art. 52(8) (conformity assessment); MDR Annex XIII (documentation requirements for custom-made devices). Custom-made devices are subject to a specific, lighter-touch regulatory pathway but must still meet all applicable GSPR.
Single-use devices & reprocessing
MDR Art. 2(8) (single-use definition); MDR Art. 17 (reprocessing of single-use devices); MDR Annex I §23.4(h) (IFU requirements for single-use designation). Reprocessing of single-use devices is regulated — not prohibited — but the reprocessor takes on full manufacturer obligations.
Companion diagnostics
IVDR Art. 2(7) (definition); IVDR Art. 48(3) (mandatory EMA/NCA consultation); IVDR Annex VIII Rule 2 (Class C minimum for companion diagnostics). Companion diagnostics require mandatory coordination between the IVDR pathway and the pharmaceutical regulatory pathway.
Near-patient & self-test IVDs
IVDR Art. 2(4)–(5) (definitions); IVDR Annex VIII Rules 6–7 (classification impact of self-test and near-patient format); IVDR Annex I §20 (GSPR for near-patient and self-test devices). Self-test IVDs are generally upward-classified and face additional usability requirements.
Legacy & grandfathered devices
MDR Art. 120 (transitional provisions for MDD/AIMDD devices); IVDR Art. 110 (transitional provisions for IVDD devices); Regulation (EU) 2023/607 (amended MDR transitional dates); Regulation (EU) 2024/1860 (amended IVDR transitional dates).
Systems & procedure packs
MDR Art. 22 governs systems and procedure packs — combinations of products that are assembled together for a specific medical purpose. The person assembling a system or procedure pack takes on specific regulatory obligations.