Abstract

A STUDY ON REGULATORY APPROVAL PROCESS OF ACTIVEIMPLANTABLE MEDICAL DEVICES (AIMDs) IN EUROPEAN UNION & REGULATIONS EU MDR 2017/745

B. Lakshmi Kanth*, M. V. Nagabhushanam, G. Ramakrishna, S.K. Sanjuda and M. Beena Devi

Abstract

The European Medical Device Regulation (MDR) is a set of regulations that governs the production and distribution of medical devices in Europe, and compliance with the regulation is mandatory for medical device companies that want to sell their products in the European marketplace. Manufacturers must develop a suite of MDRcompliant regulatory systems, processes, and documents to continually monitor the safety and performance of their products. The current Medical Devices Regulation (EU 2017/745) has replaced the Medical Devices Directive (93/42/EEC) as the legislation detailing the requirements that manufacturers must meet to place medical devices on the market in the European Union. All manufacturers of Class I to III medical products must familiarize themselves with the new requirements. As one of the highest risk categories of device, Active Implantable Medical Devices (AIMDs) are subject to rigorous regulatory controls before they can reach global markets. The Medical Device Regulation (MDR) (EU) 2017/745 defines the requirements of these medical devices.

Keywords: European Medical Device Regulation, Active Implantable Medical Devices (AIMDs), Medical Devices Regulation (EU 2017/745).