Uyarı sistemiMadde 17- Cihazın piya

Uyarı sistemi
Madde 17- Cihazın piyasaya arz edilmesinden sonra tespit edilen olumsuzluklara ilişkin uyarı
sistemi şöyledir:
a) Bakanlık, I., IIa., IIb. veya III. Sınıf bir cihaza bağlı olan ve aşağıda belirtilen olaylar ile ilgili
olarak bilgisine sunulan verilerin, bu Yönetmelik hükümlerine uygun şekilde değerlendirilmesi için
gerekli tedbirleri alır. Bunlar:
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1) Cihazın özelliklerinin ve/veya performansının bozulması veya sapması, hastanın veya
kullanıcının sağlık durumunda ciddi bozulmaya veya ölüme yol açabilecek veya yol açmış olan
kullanım kılavuzu ve etiketteki yetersizlikler,
2) Aynı tip cihazların üreticisi tarafından cihazın piyasadan sistematik olarak geri çekilmesine
yol açan ve bu bendin (1) numaralı alt bendinde belirlenen sebepler için bir cihazın özelliklerine ve
performansına bağlı teknik ve tıbbî sebepler.
b) Üretici veya üreticinin Türkiye dışında olması durumunda onun yetkili temsilcisi, hekim
veya sağlık kurum ve kuruluşları, bu maddenin (a) bendinin (1) numaralı alt bendinde belirtilen
durumlar hakkında Bakanlığı bilgilendirmek zorundadırlar. Bakanlık, hekim veya sağlık kurum ve
kuruluşlarından gelen bildirimlerle ilgili olarak cihazın üreticisinin veya üreticinin Türkiye dışında
olması durumunda onun yetkili temsilcisinin bu durumdan haberdar olması için gerekli bütün tedbirleri
alır.
c) Bakanlık gerekirse, üretici veya üreticinin Türkiye dışında olması durumunda onun yetkili
temsilcisi ile birlikte, konuyu yerinde inceler ve değerlendirme sonucundan, bu Yönetmeliğin 18 inci
maddesindeki hususlar saklı kalmak kaydıyla, Müsteşarlık kanalıyla Komisyon’a bilgi verir.

結果 (英文) 1:

Warning systemArticle 17-the device on the market after the negativity of the warningsystem is as follows:a) Ministry, I, Iia, Iib. or III. Class, to a device that is connected to and below the specified events associated withthe data that is presented to the information, in accordance with these regulations for the evaluation oftake the necessary measures. These are:81) properties of the device and/or performance degradation or deviation, the patient orthe health of the user in the case of serious deterioration could lead to or have led to the death or theuser manual and inefficiencies in the label,the leading manufacturer of devices of the same type 2) by the withdrawal from the market of the device as a systematicled and this paragraph (1) is a device for the reasons specified in the properties andDepending on the performance of technical and medical reasons.b in the case of the Manufacturer or the manufacturer of the Turkey outside) its authorized representative, physicianor health institutions and organizations, this article is (a) of subsection (1) in the specifiedare required to inform the Ministry about the situation. The Ministry, the physician or health institutions andOrganization in relation to the notification from the device manufacturer or the manufacturer's Turkey outsidein the case of his authorized representative that all necessary measures to be informedgets.c) Ministry, if necessary, in the case of the manufacturer or his authorized manufacturer of Turkey outsideRepresentative examines and reviews at the subject, with the result that the regulation 18thwithout prejudice to article subjects, provides information to the Commission through the Uft.

結果 (英文) 3:

Warning system
Article 17- the market after the car has been offered for the fallout warning
system are as follows:
a) The Ministry, I. , IIa IIb.,. or III. The device is connected to a Class and all of the following events as If information related to the data, so that according to the provisions of this Directive for the assessment of
take the necessary measures. These are:
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1) features of the device performance and/or corruption or deviation, if the patient's health, or
user serious deterioration or death or a road that can lead to a2 for the currently logged-on user's guide and poor,
2) is the same type by the manufacturer of the device to be withdrawn are commercially available as a systematic
and that causes this to (1), in the lower the causes for the a2 performance specifications, and technical and medical reasons.
b) manufacturer or the manufacturer's Turkey out of its authorized representative in the event of a physician, or If the health care institutions and organizations this article bendinin (a) (1), in the lower the
They have to inform Ministry of states are about. Ministry, physician or health care institutions and organizations from
from the device to the manufacturer or the manufacturer's Turkey in the event of a
out of its authorized representative for the state to be aware of all the necessary measures for the
.
c) The Ministry if necessary,Manufacturer or the manufacturer's Turkey in the event of a out of its authorized representative If a topic, along with reviews and assessment outcome in place, the 18 th
substance points to be stored, through the Deputy provides information to the Commission.