Under Medical Device Rules MDR – 2017, close to 80 IVDmedical devices have been categorized depending on the intention of its use, the risk associated with it, and other such parameters. All these classified devices are roofed under various categories such as clinical chemistry, immunology, microbiology, and hematology. There are several other categories for efficient regulation as well as safety of the patients.
CDSCO (Central Drugs Standard Control Organization)categorized this in-vitro diagnostic device under MDR -2017 depending on the risk classified for efficient regulation.
This categorization assists companies in proper compliance to MDR – 2017 regarding the manufacture, clinical scrutinization, import, evaluation of clinical performance, sale, and fair distribution of all medical devices.
As per the new MDR Rules, Category A is for devices of low risk such as Alcohol Body fluid analyzer, Amino Acid analyzer, CreatinineAnalyzer, etc. Category B is for devices of low, moderate risk, and category Cis for moderate high-risk devices, and Category D is for high-risk devices.
The entire list is entirely dynamic and will change and be revised from time to time under provisions of MDR 2017. The new MD rules have also included medical devices, disinfectants, surgical sutures, bandages, ligatures, etc. It has set all-new standards for the manufacture and utilization of medical devices.
Under the clinical chemistry category, hematology category, immunology category, and microbiology category 5 IVD analyzers have been categorized under these rules.
All the state licensing authorities need to send required applications to the bodies, to inspect and audit class A and class B medical devices to comply with new MD rules. The machines under category C and category D are audited by CDSCO independently.
As per the notification, the software that drives the device or influences the device's use falls under the same class. That software that is not integrated into any IVDmedical device is categorized using classification provision as specified in the required of MDR 2017.
Medical device licenses are now an expedited procedure. We at CliniExperts strive to provide our clients assistance with application and licensing procedures related to MedicalDevice Regulation India and MedicalDevice Registration India.