Medical Devices
Medical Devices in NIPER JEE covers risk-based classification, Indian and US regulation, quality systems, biocompatibility, sterilization, and combination products.
Core rules and concepts
- India: Medical Devices Rules 2017, administered by CDSCO; classes A (low risk), B (low-moderate), C (moderate-high), D (high). Licensing and notified-body involvement increase with class.
- US FDA: Class I low risk (general controls), Class II (special controls, usually 510(k) substantial equivalence), Class III (premarket approval, PMA). 510(k) is not an approval; it is a clearance based on substantial equivalence.
- ISO 13485 is the medical-device QMS; ISO 14971 covers risk management; IEC 62304 covers medical-device software lifecycle.
- Biocompatibility is evaluated under ISO 10993; tests depend on contact type and duration.
- Sterilization: moist heat, ethylene oxide, gamma irradiation. SAL 10⁻⁶ means probability of a viable microorganism on a device is ≤1 in 1 million.
Worked example
A device has bioburden 10² CFU and a D-value of 2 min at the chosen cycle. To reach SAL 10⁻⁶, the required log reduction is 2 − (−6) = 8 logs. Cycle time = 8 × 2 = 16 min, before adding safety margin. This shows why bioburden and D-value must be known; a fixed cycle time is not automatically valid.
Traps that cost marks
- Calling 510(k) an approval; it is a clearance for substantial equivalence.
- Assuming all Class I devices are exempt from all controls.
- Confusing a drug–device combination product’s primary mode of action with its components.
- Treating SAL 10⁻⁶ as zero sterility risk; it is a probability statement.