PART I

Purpose, Scope, Grounds & Definitions

Purpose

ARTICLE 1 – (1) The purpose of this Regulation is to lay down the rules and procedures applicable to the sales, advertising and promotion activities for medical devices placed on the market.

Scope

ARTICLE 2 – (1) This Regulation applies to natural or legal persons that are actively engaged in the sales, advertising and promotion of medical devices subject to application of the Regulation on Medical Devices as published on the OJLA Edition 27957 of 6-7-2011, the Regulation on Active Implantable Medical Devices as published on the OJLA Edition 27957 of 6-7-2011 or the Regulation on In Vitro Diagnostic Medical Devices as published on the OJLA Edition 26398 of 1-9-2007.