Official Journal Date : 7.06.2011
Official Journal Number : 27957

The objective of this Regulation is to lay down the essential requirements medical devices and their accessories must meet and to establish the principles and procedures relating to their design, classification, manufacture, placing on the market, putting into service, and inspection for the purpose of providing safeguard measures for patients, appliers, users and third parties against possible hazards they may be exposed to as regards their health and safety during the use of such devices and their accessories. This Regulation covers all the activities of public institutions and establishments and natural and legal persons regarding the design, manufacture, placing on the market, putting into service and inspection of medical devices and their accessories.

tıbbi cihazlar; tıbbi cihaz ve aksesuarlarının tasarımı, üretimi, dağıtımı ve kullanımı; tıbbi cihazların ithalatı; uygunluk beyanı; tip incelemesi; tip doğrulaması; tip uygunluk beyanı; ürün kalite güvencesi uygunluk beyanı; özel amaçlı cihazlara ilişkin beyan; CE İşareti; CE İşareti taşıması gereken ürünlerin ithalatı