EU MDR 2017/745 Introduction (PART I)
Welcome to an Introduction to European Union Medical Device Regulations 2017/745. This module is an introductory module to explain how, why and when the new regulations have come into force, what they consist of and some of the new and strengthened features. We will look at some of the historical events that have occurred over a period of decades and their consequences and we will be able to see the triggers for changes in legislation and understand what brought these changes about. This module includes a high-level overview of the contents of EU MDR 2017/745, some of the new features, the timelines for compliance and we’ll take a look at how the new MDRs compare to MDD.
EU MDR 2017/745 Scope and Definitions (PART I)
There are only four articles in this chapter. Articles 3 and 4 are comparatively short so naturally we shall spend the bulk of the time in this module examining Articles 1 and 2. In this module, we will cover Article 1 – the Subject Matter and Scope, which sets out what this regulation applies to as well as what this regulation does NOT apply to. We shall also examine where a decision is required to determine which set of regulations (other than EU MDR 2017/745) a product is governed by. We will also cover Article 2 - Definitions which set out a list of 71 definitions of devices or groups of devices which apply for the purposes of this regulation. Many of the definitions should be known to workers in the medical device industry and are given in the section “Commonly Understood Definitions”. It is not our intention to walk through all of the definitions in this module but, rather, focus on some of the more notable ones.