Latest Risk Management guideline (ISO 14971:2019) & Environmental aspects of Medical Device

  • Sunaina Mishra Drug Regulatory Affairs
  • Vikesh Kumar Shukla


The use of medical device in patient is a critical step and requires an appropriate management system for its best practice and use throughout its complete lifecycle. Various countries around the globe have procedures and regulations in place for the safe production and use of their medical device. CDSCO, GOI (Government of India) under directorate general of health services in ministry of health and family welfare are the governing body in India which is responsible for the safe & effective use of medical device on patients under Medical Device Regulations, 2017. Recently, the third version of ISO 14971:2019 series has been notified and several aspects of this regulation include the best objectives to be achieved by the manufacturer by being compliant with the risk management plan set forth in the international standard on risk management system. ISO 14971 for medical device ensure companies produce a product which is safe and effective for use and for patients who unknowingly tend to accept the risk related to medical device which the experts design and manufacture. Risk management standard help a manufacturer build a risk management plan and carry out activities in compliance with the international guideline so as to minimize the risk possibility, occurrence and any hazard associated with it. This article focuses on the importance of ISO 14971 and structure the aim and standard. It also throws light towards the environmental aspects as an element of the management process relating to the threat posed to the surroundings by their use, as well as with various other steps taken by the companies to make the public aware of the product they use and unknowingly support the risk posed by the material that the product is composed of. Bio medical waste management is an initiative undertaken by India for the safe disposal and treatment of bio medical waste generated around us by various primary and secondary sources. This article gives a brief overview of guidance on risk assessment, management and control plans to be implicated by the company and steps taken to tackle and reduce harm to the environment posed by medical devices.

Keywords: Medical device, Risk Management System, Risk Management Plan, Biomedical Waste Management, Hazard, Safety & Efficacy, BRA, Sustainability, Environment


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1. Medical device rules India, 2017. Classification of medical devices regulations and regulatory approval for registration [Internet]. 2017 [Cited 2020 Mar 5]. Available from:
2. Suraj pamadi. Medical Device Regulations in India. Slide share [Internet]. 2015 Mar 30 [Cited 2020 Mar 5]. Available from:
3. Meseret N. Teferra. ISO- 14971 Medical Device Risk Management Standard. International Journal of Latest Research in Engineering and Technology [Internet]. 2017 Mar [cited 2020 Mar 6]. Available from:
4. Jon Speer. The Definite Guide to ISO 14971 Risk Management for Medical Devices. Greenlight guru [Internet]. 2020 Feb 25 [Cited 2020 Mar 08]. Available from:
5. Nancy Crotti How to Design a Sustainable Medical Device [Internet]. 2019 Apr 10 [cited 2020 Mar 09] Available from:
6. Jenna Tsui How Are Medical Devices Making Consumers More Environmentally Conscious [Internet]. 2020 Mar 02 [Cited 2020 Mar 9]. Available from:
7. IEC 60601-1-9 environmentally conscious design. Intertek Group plc Total Quality Assured [Internet]. [Cited 2020 Mar 10]. Available from:
8. ISO 14971 Risk Management Consulting for Medical Device Companies. [Internet]. Emergo [Cited 2020 Mar 10]. Available from:
9. Ann vankrunkelsven. What are the 3 main changes in the new ISO 14971 version? [Internet]. 2019 Dec 20 [cited 2020 March 11]. Available from:
10. Marcelo Trevino. Analysing the Changes to Risk Management Standard ISO 14971:2019. Med device online [Internet]. 2019 Dec 11 [cited 2020 March 13]. Available from:
11. Hazard ad hazardous situation. The Johner institute for healthcare IT [Internet]. [cited 2020 Mar 13]. Available from:
12. Fatemeh Rezaei, Mohmmad H. Yarmohammadian, Abbas Haghshenas, Ali Fallah and Masoud Ferdosi. Revised Risk Priority Number in Failure Mode and Effects Analysis Model from the Perspective of Healthcare System. Int J Prev Med. 2018; 9:7. [Internet]. NLM; 2018 Jan 29 [Cited 2020 Mar 16]. Available from:
13. Jos van vroonhoven. Production, post- production and the new ISO 14971 [Internet] 2019 Sept 05 [cited 2020 Mar 16]. Available from:
14. Government of India ministry of environment, forest and climate change. [Internet]. 2016 Mar 28 [cited 2020 Mar 20]. Available from:
15. WHO. Review of Health Impacts from Microbiological Hazards in Health-Care Wastes. Geneva: World Health Organization. [Internet] 2004 [cited 2020 Mar 20]. Available from:
16. Revised Guidelines for Common Bio-medical Waste Treatment Facilities. Central pollution control board (Ministry of Environment, Forest and Climate Change) [Internet]. 2016 Dec 21. [cited 2020 Mar 24]. Available from:
17. Priya Datta, Gursimran Kaur Mohi, and Jagdish Chander. Biomedical waste management in India: Critical appraisal [Internet]. 2018 Jan-Mar [cited 2020 Mar 24]; 10(1): 6–14. Available from:
18. Anurag V. Tiwari and Prashant A. Kadu. Biomedical waste management practices in India – A review International Journal of Current Engineering and Technology vol. 3, no.5 [Internet]. Researchgate; 2013 Dec [cited 2020 Mar 26]. Available from:
19. B. Ramesh Babu, A.K. Parande, R. Rajalakshmi, P. Suriyakala, M. Volga. Management of Biomedical Waste in India and Other Countries: A Review J. Int. Environmental Application & Science, Vol. 4 (1): 65-78 (2009). [Internet]. 2009 Mar 16 [cited 2020 March 26]. Available from:
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How to Cite
Mishra, S., and V. K. Shukla. “Latest Risk Management Guideline (ISO 14971:2019) & Environmental Aspects of Medical Device”. International Journal of Drug Regulatory Affairs, Vol. 8, no. 2, June 2020, pp. 15-24, doi:10.22270/ijdra.v8i2.387.

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