Medical Devices are widely used in all branches of medicine, surgery and community not only in India but across the globe. To keep in view, that the broad objective is to ensure the protection of the health & safety of patients, healthcare professionals and others, the Ministry of Health & Family Welfare, Government of India has released the Medical Device As Per MDR 2017 effective from 1st January, 2018 for regulating Medical Devices being used in the Country.

Introduction to Medical Devices As Per MDR 2017

The Medical Device Rules 2017, comes into effect on 1 January 2018. This provides a comprehensive framework for the regulation of medical devices in India. Through this legislation medical device importers, manufacturers, and wholesalers ensure that they meet the quality and safety standards, promoting the well-being of users.

What is a Medical Device?

As per the Medical Device Rule 2017, Medical Device refers to an instrument, apparatus, appliance, implant, material, or other articles, including software or accessories, intended for use in:

• Diagnosis, prevention, monitoring, treatment, or alleviation of any disease.
• Diagnosis, monitoring, treatment, alleviation, or assistance for any injury or physical disability.
• Investigation, replacement, or modification of the anatomy or a physiological process.
• Control of conception.

Scope of Medical Devices and Substances Defined Under MDR 2017

• Any substances used for in vitro diagnosis, surgical dressings, surgical bandages, surgical staples, surgical sutures, ligatures, blood and blood component collection bag with or without anticoagulant. (All medicine for internal or external use of human beings or animals and all substances intended to be used for or in the diagnosis, treatment, mitigation or prevention of any disease or disorder in human beings or animals including preparations applied on the human body to repel insects like mosquitoes.)
• Equipments that includes mechanical contraceptives (condoms, intrauterine devices, and tubal rings), disinfectants and insecticides (substances, other than food, intended to affect the structure or any function of the human body or intended to be used for the destruction of insects which cause disease or disorder in human beings or animals.)
• Any devices intended for internal or external use in the diagnostics, treatment, mitigation or prevention of disease or disorder in human beings or animals, as the Central Government may specify from time to time.

Categories of Medical Devices As Per MDR 2017

When an importer, manufacturer, or wholesaler applies for the license as per the Medical Device As Per MDR 2017 then they must first check the category of the medical devices. Because as per the risks of medical devices are categorised into four categories, as follows:

• Class A: Low risk (e.g., surgical dressings)
• Class B: Low to moderate risk (e.g., infusion pumps)
• Class C: Moderate to high risk (e.g., orthopaedic implants)
• Class D: High risk (e.g., heart valves, pacemakers)

Key Features of MDR 2017 for Medical Devices

Here are some key features that are defined as per the MDR 2017 that you must understand about it.

• Risk-based Classification: Devices are regulated according to their potential risk to users.
• Registration and Licensing: Mandatory registration and licensing for manufacturers, importers, and distributors.
• Quality Standards: Adherence to ISO standards like ISO 13485 for quality management.
• Clinical Evaluation: Necessary for high-risk devices before market approval.

Importance Of Medical Device As Per MDR 2017 in Healthcare

MDR 2017 ensures that the medical devices used in India are safe, effective, and meet global quality standards. This will boost the healthcare professionals among patients while aligning India’s regulatory framework with international norms.

Conclusion – Medical Device As Per MDR 2017

The definition of medical devices under MDR 2017 emphasizes their role in healthcare, focusing on safety and functionality. Proper understanding and compliance with these regulations are crucial for manufacturers and stakeholders in the medical device industry.