Medical Devices Rules 2017 — Overview
What is MDR 2017?
The Medical Devices Rules 2017 (MDR 2017), notified on 31 January 2017 and in force from 1 January 2018, is the comprehensive subordinate legislation that establishes the detailed framework for medical device regulation in India. It was made under the Drugs and Cosmetics Act 1940.
Structure
MDR 2017 contains eight chapters and seven schedules:
Chapters
| Chapter | Rules | Subject |
|---|---|---|
| Chapter I | 1–3 | Preliminary — short title, commencement, definitions |
| Chapter II | 4–7 | Classification of medical devices |
| Chapter III | 8–17 | Import of medical devices |
| Chapter IV | 18–36 | Manufacture of medical devices |
| Chapter V | 37–45 | Clinical investigation |
| Chapter VI | 46–54 | Vigilance |
| Chapter VII | 55–62 | Labelling and IFU |
| Chapter VIII | 63–75 | Licensing authorities, appeals, and miscellaneous |
Schedules
| Schedule | Subject |
|---|---|
| Schedule 1 | Notified medical devices |
| Schedule 2 | Notified IVDs |
| Schedule 3 | Labelling requirements |
| Schedule 4 | Essential Principles |
| Schedule 5 | GMP requirements (Part I and Part II) |
| Schedule 6 | Clinical investigation requirements |
| Schedule 7 | Vigilance requirements |
Key amendments
- MDR 2017 Amendment Rules 2020 — expanded device scope
- MDR 2017 Amendment Rules 2021 — UDI, vigilance updates
- MDR 2017 Amendment Rules 2023 — further scope expansion
Official source: MDR 2017 — CDSCO