CDSCO classifies 80 IVD medical devices under new medical device rules for their effective regulation

The Central Drugs Standard Control Organisation (CDSCO) has classified around 80 in-vitro diagnostic (IVD) medical devices under Medical Device Rules (MDR) -2017 based on risk based classification for their effective regulation.

“This will help companies in effective compliance to MDR-2017 with respect to the import, manufacture, clinical investigation, clinical performance evaluation, sale and distribution of medical devices,” the Drugs Controller General of India (DCGI) Dr V G Somani.

According to the new MDR rules, Class A is for low risk, Class B for low moderate risk, Class C for moderate high risk and Class D for high risk.

Around 80 IVD medical devices have been classified under the MDR 2017 based on the intended use, risk associated with the device and other parameters. These 80 classified devices are covered under categories of clinical chemistry, hematology category, immunology and microbiology among others for effective regulation and patient safety.

“This list is dynamic and is subject to revision from time to time under the provisions of the MDR – 2017,” the DCGI further stated.

New MD Rules 2017 covers medical devices, in-vitro diagnostics (IVDs), disinfectants, surgical sutures, ligature, condoms, bandages etc. It sets new standards for manufacturing and use of medical devices.

Around 20 devices in the clinical chemistry category, 13 in the hematology category, 8 in immunology category and 7 in microbiology categories including 53 IVD analysers have been classified.

The new MD Rules 2017 were notified last year and came into effect from January 1, 2018 onwards in the country. Following the notification, issues related to post grant compliance, data protection, product recalls and product liabilities among others will be implemented effectively towards device or product safety.

State Licensing Authorities (SLAs) have to send applications to the notified bodies for inspections and auditing of Class A and Class B category medical devices towards compliance to the new MD Rules. Class C and Class D categories are audited by the CDSCO independently as per the new MD Rules.

The notice says that the software, which drives a device or influences the use of a device, falls automatically in the same class. Software that is not incorporated in an IVD medical device, shall be classified using the classification provisions as specified in the relevant portion of MDR -2017.

The Central Government, after consultation with the Drugs Technical Advisory Board (DTAB) had notified MDR- 2017 effective from January 1, 2018.