MedDO Classification Rules 1–22
Non-Invasive Devices (Rules 1–4)
Rule 1 — All non-invasive devices are Class I unless a specific rule applies. Example: bandages, examination gloves. Rule 2 — Non-invasive devices channelling/storing blood or body fluids: Class IIa (if connected to active Class IIa+), else Class I. Example: blood bags (IIa). Rule 3 — Non-invasive devices modifying biological/chemical composition of blood or fluids: Class IIb unless used for filtration/centrifugation/gas exchange. Example: dialysers (IIb). Rule 4 — Non-invasive devices in contact with injured skin: Class I (minor wounds), IIa (non-mechanically compromised wounds), IIb (deep wounds with dermal breach). Example: hydrocolloid dressings (IIa), deep wound absorbent dressings (IIb).
Invasive Devices (Rules 5–8)
Rule 5 — Invasive via body orifices, short-term: Class I (disposable, external orifice), IIa (digestive/urinary/injured mucous membrane), IIb (cardiovascular or active). Example: urinary catheters (IIa), cardiovascular guidewires (IIb). Rule 6 — Surgically invasive, transient/short-term: Class IIa generally; IIb if active, cardiovascular, or CNS contact; Class III for cardiovascular with biological effects. Example: surgical instruments (I/IIa), cardiac catheters (IIb). Rule 7 — Surgically invasive, long-term/permanent: Class IIb generally; Class III for cardiac, vascular, or CNS implants and absorbable implants; Class IIa for bone screws/plates and dental/bone substitutes. Example: titanium screws (IIa), cardiac stents (III). Rule 8 — Implantable devices: Class III by default with specific downgrades to IIb or IIa for low-risk implants (sutures, dental restorations). Example: pacemakers (III), dental crowns (IIa).
Active Devices (Rules 9–13)
Rule 9 — Active therapeutic: Class IIa (energy exchange with patient); IIb (potentially dangerous); Class III (directly dangerous energy delivery, e.g. defibrillators). Example: physio equipment (IIa), surgical lasers (IIb), defibrillators (III). Rule 10 — Active diagnostic/imaging: Class IIa (energy absorbed by patient); IIb (radiopharmaceutical imaging or hazardous radiation). Example: ultrasound (IIa), X-ray systems (IIb). Rule 11 — Active devices administering/removing medicines: Class IIb generally; Class III if potentially dangerous administration. Example: infusion pumps (IIb), implantable drug delivery (III). Rule 12 — All other active devices: Class I. Example: electrically operated examination tables. Rule 13 — Active devices administering diagnostic/monitoring substances: Class IIa. Example: contrast agent injectors.
Special Rules (Rules 14–22)
Rule 14 — Devices incorporating a medicinal substance as integral part: Class III. Example: antibiotic bone cement, heparin-coated catheters. Rule 15 — Devices incorporating viable animal/human tissue: Class III. Example: vascular xenografts. Rule 16 — Devices specifically for recording X-ray diagnostic images: Class IIa. Example: digital X-ray detectors. Rule 17 — Non-viable animal tissue/derivatives: Class III unless exclusively external contact (Class I or IIa). Example: porcine pericardial patches (III). Rule 18 — Non-viable human tissues/cells: Class III. Example: decellularised human tissue matrices. Rule 19 — Nanomaterials: Class III (intentionally released), IIb (high/medium exposure), IIa (low exposure). Rule 20 — Invasive devices for the spine (interbody): Class III. Example: interbody fusion cages. Rule 21 — Substances absorbed by or dispersed in the body: Class III if systemic absorption or specific tissue presence. Example: absorbable haemostatic agents. Rule 22 — Closed-loop systems including software for serious conditions: Class III. Example: automated insulin delivery systems.
Official Sources
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