Medical Device becoming more important in the health care sector. Today there are more than 8000 generic medical device groups where some devices contain drugs. This increases the demand for better regulatory frameworks to ensure that products entering the market are safe and efficient.
Every medical device is regulated in some way by Regulatory agencies, Such as FDA, European Commission, Health Canada. These regulatory agencies have defined a bunch of rules and regulations (or “laws”) regarding medical devices. Each regulatory agency has defined several different classifications for medical devices. But all agencies are classified medical device on the bases of risk. So, all the medical device are classify depending upon risk.
Medical device classification is important for the following reason;
According to EU Medical Device Directive (MDD) and EU Medical Device Regulation (MDR), Medical Device Classification is based on the inherent risks posed by the devices. Article 9 of EU Medical Device Directive (MDD) describes about Medical Device classification where as EU MDR 2017/745 decribes about classification in Article 51.
Although the medical device classification system itself has not changed, several new rules regarding the classification of substance-based devices have been established. All devices containing substances that will be introduced to and/or absorbed by the body will rely on a totally different classification system. As a result, many devices will be reclassified to higher-risk classes. This has been detailed in the following Articles: 1, 2, 22, 23, 51, and 52.
In MDD there were 18 rules, where as in MDR new rules are added hence there are total 22 rules. As per the rules some of the devices may be reclassified to higher category or lower category.
|Medical device classification||Ø Class I (e.g. Corrective glasses and frames, Stethoscopes)|
Ø Class IIa (e.g. Infusion cannulae, clamps)
Ø Class IIb (e.g. Intraocular lenses, non-absorbable sutures, bone cements)
Ø Class III (e.g. Cardiovascular catheters i.e. angioplasty balloon catheters, stent delivery catheters/systems),
|Ø Class I (e.g. Corrective glasses and frames)|
Ø Class Is (sterile)-(e.g. personal protection kits)
Ø Class Im (measuring body attributes)-(e.g. Stethoscope, weighing balance)
Ø Class Ir (reuse)-(e.g. surgical forceps)
Ø Class IIa (e.g. Surgical gloves, lancets, Orthodontic wires)
Ø Class IIb (e.g. Intraocular lenses, Orthopedic implants like bone plates and nails)
Ø Class III (e.g. Breast implants or surgical meshes, stents, spinal implants),
|Rules||Rules 1- 4: Non-invasive Devices|
Rules 5 – 8: Invasive Devices
Rules 9 – 12: Active Devices
Rules 13 – 18: Special Rules
|Rules 1- 4: Non-invasive Devices|
Rules 5 – 8: Invasive Devices
Rules 9 – 13: Active Devices
Rules 14 – 22: Special Rules
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