Cover Story

Medical Device & In Vitro Diagnostic Devices:
MDR 2017 and Industry Preparedness

Subsequently, close interactions between regulatory body and industry associations (AiMED, ADMI) lead to development & notification of Medical Device Rules 2017 paving way for structured regulation of MD-IVD in country. From 1st January, 2018 these Rules brought a paradigm shift in regulatory procedure for MD-IVD in country along with clarity on classification of devices, requirement of technical documentation, customization of application forms, fee structure, timelines. This helped several manufacturers to prepare themselves and submit applications on easy-to-use MD-Online Portal of CDSCO. More so a manufacturer specific dedicated dash board added value for each user. Large number of manufacturer’s completed their transition of licenses from D&CAct to MDR2017 by end of 2019 with many more in progress. Simultaneously regulation was preparing to bring more MDIVD under the ambit of MDR Rules 2017.

Two gazette notifications which were published in February 2020 were significant. One expanded the definition of medical devices (Refer Box 1) and another advised the actions to be taken by industry (Figure 1). Before it could get into industry awareness sessions the country was hit by pandemic. As a blessing in disguise entire country learnt about Ventilators, PPEs, VTM, RNA- Extraction Kits, RTPCR, Antibody Tests and Antigen Tests were all over NEWS papers and TV. Many also learnt about ICMR and CDSCO for the first time as Import Permissions were given and Emergency Manufacturing Licences were given. MD-IVD-Regulation all were at forefront.

Box-1 Definition of Medical Devices under Medical Device Rules 2017 and Amendment 2020

 

Before 11th February 2020 “medical device” means,- (A) substances used for in vitro diagnosis and surgical dressings, surgical bandages, surgical staples, surgical sutures, ligatures, blood and blood component collection bag with or without anticoagulant covered under sub-clause (I), (B) substances including mechanical contraceptives (condoms, intrauterine devices, tubal rings), disinfectants and insecticides notified in the Official Gazette under sub-clause (ii), (C) devices notified from time to time under sub-clause (iv), of clause (b) of section 3 of the Act; Explanation: For the purpose of these rules, substances used for in vitro diagnosis shall be referred as in vitro diagnostic medical device.

From 11th February 2020 All devices including an instrument, apparatus, appliance, implant, material or other article, whether used alone or in combination, including a software or an accessory, intended by its manufacturer to be used specially for human beings or animals which does not achieve the primary intended action in or on human body or animals by any pharmacological or immunological or metabolic means, but which may assist in its intended function by such means for one or more of the specific purposes of ― (I) diagnosis, prevention, monitoring, treatment or alleviation of any disease or disorder; (ii) (ii) diagnosis, monitoring, treatment, alleviation or assistance for, any injury or disability; (iii) investigation, replacement or modification or support of the anatomy or of a physiological process; (iii) (iv) supporting or sustaining life; (iv) (v) disinfection of medical devices; and (v) (vi) control of conception.

A large number of manufacturers and importers of newly notified medical devices have not seen and experienced the requirements given in MDR 2017 owing to the fact that these were not regulated until February 2020. The Figure 2 shall help them know that compliance to these Rules needs several levels of preparedness such as a) clear understanding of Rules, b) requirements of infrastructure, c) QMS & Quality and d ) requirements of personnel. It is easy for some and nightmare for many. The different chapters, schedules and appendix of MDR 2017 and Amendment 2020 offer excellent guidance to prepare for all these segments. Industry can also take services from Consultants who have medical device domain knowledge and experience. It would be pertinent and effective to undergo a comprehensive training for clear understanding. All kinds of conflict of interests shall be addressed while hiring a consultant and all consultancy shall be availed against a signed quality agreement as per firm’s outsourcing SOP.

The Good Manufacturing Practices (GMP) for MD-IVD have been covered under Quality Management System (QMS) explained under Fifth Schedule of MDR2017. While licensing process application does not require ISO13485 certificate, the registration process requires ISO 13485 certificate to be uploaded on portal. This is significant as this requirement necessitates implementation of ISO13485 and a certification. All manufacturers and importers shall make all efforts to understand ISO13485 and integrate their existing processes with processes required by standard.