Medical Device Risk Classes: EU_MDR
Medical device regulatory classification rules, risk levels, and required regulatory pathways. Covers four frameworks: FDA 21 CFR Part 860 (Class I / I_non-exempt / II / II_De_Novo / III / III_HDE / III_PDP with 510(k)/De_Novo/PMA/HDE pathways), EU MDR 2017/745 (Class I variants: non-sterile_non-measuring, sterile, measuring, reusable_surgical; Class IIa, IIb, III; Notified Body requirements and PSUR/PMCF obligations), ISO 14971:2019 risk management severity scale (Severity_1_Negligible through Severity_5_Catastrophic with probability/risk matrix guidance), and IEC 62304:2006+AMD1:2015 medical device software safety classes (A: no harm, B: non-serious injury, C: death or serious injury) with SDLC documentation requirements. Each record includes device examples, regulatory pathway, premarket requirements, postmarket obligations, key classification criteria, and cross-reference to applicable IEC 62304 software safety class.
| regulatory framework | device class | class description | device examples | key criteria | notes | postmarket requirement | premarket requirement | regulatory pathway | risk level | software relevance |
|---|---|---|---|---|---|---|---|---|---|---|
| EU_MDR | Class_III | Highest Conformity Assessment | Heart valves, pacemakers, cochlear implants, drug-eluting stents, total joint replacement implants, spinal implants (metallic), breast implants, active implantable devices that interface with heart/CNS/brain | Life-sustaining or life-supporting implants; highest risk; mandatory clinical investigation data usually required; NB must consult EU expert panel (for certain novel devices); Rules 13-22 and implantable rule 8 primarily | NB must review clinical data and may require consultation with EU expert panel for novel Class III devices per Article 54; SSCP updated annually; EUDAMED public access; post-market clinical follow-up (PMCF) mandatory and annual; 10-year technical documentation retention | Annual_PSUR + PMCF_annual + vigilance + SSCP | QMS_audit + clinical_evaluation_with_NB_scrutiny + annual_PSUR | CE_mark_via_Notified_Body_with_clinical_scrutiny | Highest | IEC_62304_Class_C |
| EU_MDR | Class_IIa | Conformity Assessment via Notified Body | Catheters (short-term invasive), hearing aids, surgical stapling devices, dental restorative materials, endoscopes (reusable non-implantable), contact lens care solutions, infusion tubing, laryngoscopes | Short-term invasive or non-invasive devices with more risk than Class I; typically <30 days contact; body orifice or surgically invasive; Notified Body must audit Technical Documentation and QMS; Rules 5-8 primarily | NB issues EU Technical Documentation Assessment certificate; manufacturer must demonstrate SSCP (Summary of Safety and Clinical Performance) for implantables; PMCF plan required; EUDAMED public access to SSCP; periodic safety reports every 2 years for IIa | PMS + PMCF + vigilance + periodic_summary_safety_update | Notified_Body_audit + Technical_doc + Clinical_evaluation | CE_mark_via_Notified_Body | Low-Moderate | IEC_62304_Class_B |
| EU_MDR | Class_IIb | Conformity Assessment via Notified Body | Ventilators, infusion pumps, long-term contact lenses (>30 days), urinary catheters (>30 days), therapeutic x-ray sources, defibrillators (external), bone cement, sutures (absorbable), implantable mesh (hernia) | Medium-to-high risk; longer-term invasive or active therapeutic devices; includes devices implanted >30 days not Class III; Notified Body audits QMS (typically Annex IX) + Technical Documentation; Rules 9-12 primarily | NB QMS audit scope covers design + manufacturing + QMS; PSUR (Periodic Safety Update Report) annually; SSCP for implantable class IIb; EUDAMED submission mandatory; clinical data must demonstrate benefit-risk ratio acceptable | PMS + PMCF annual + vigilance + annual_PSUR | Notified_Body_QMS_audit + Technical_doc + Clinical_evaluation | CE_mark_via_Notified_Body | Moderate-High | IEC_62304_Class_B_or_C |
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