Glossary

Medical Devices

What are Medical Devices?

Medical devices are instruments or machines used for medical diagnosis, treatment, and disease prevention. They vary from simple tools like thermometers to advanced technologies such as MRI machines and pacemakers. Regulation is essential due to associated risks. In the U.S., the FDA ensures safety and efficacy of medical devices, while similar regulations, like the Medical Device Regulation (MDR), exist in Europe.

Medical devices are classified into 3 different classes by the FDA such as

  • Class I devices are low-risk devices. Examples include bandages, handheld surgical instruments, and nonelectric wheelchairs
  • Class II devices are intermediate-risk devices
  • Class III devices are high-risk devices very important to health or sustaining life.

What are the FDA regulations for Medical Devices industry?

21 CFR Part 820: Quality System Regulations (QSR) governing medical device manufacturing processes

21 CFR Part 11: Regulations for electronic records and signatures

 21 CFR Part 803: Requirements for reporting adverse events and device malfunctions

Device Classification based on the level of risk, with Class III devices requiring the most stringent regulatory controls, including Premarket Approval (PMA)

What are the EU regulations for Medical Devices industry?

The European Union Medical Device Regulation (EU MDR), established by Regulation (EU) 2017/745, governs the production and distribution of medical devices within the EU. The regulation classifies devices based on risk, mandates rigorous clinical evaluations, and emphasizes post-market surveillance to monitor device performance. It also introduces requirements for Unique Device Identification (UDI) and enhances transparency and traceability in the medical device sector, thereby supporting innovation and public health safety.

What are the regulations for medical devices industry in India?

The Central Drugs Standard Control Organization (CDSCO) is India’s national regulatory authority for medical devices, cosmetics and pharmaceuticals, operating under the Drugs and Cosmetics Act and the Medical Device Rules, 2017. Medical devices in India are classified into four categories (A, B, C, D) based on their risk levels, with registration and licensing required for their manufacture, sale, and distribution. The CDSCO ensures compliance with Indian standards or internationally recognized standards to maintain quality. Additionally, the organization conducts post-market surveillance, which includes adverse event reporting and continuous monitoring of devices to ensure ongoing safety and effectiveness in the healthcare system.