Thank you Sir.
If you have the any guidance concerned, we would appreciate it if you could attache them in this website.
Kind regards,
Mickey
This link is a translated version of the Turkish law implementing MDD. See Article 6. <Sorry, can't post links cause of forum rules...>
Ok, go to google translate, enter saglik.gov.tr, go to website, Health Legislation, Regulations (second from top), Regulation of Medical Devices, click for additional documents, go to Article 6.
Article 6 - (1) subject to conformity assessment procedures maintained in accordance with the provisions of this Regulation and CE marking of medical devices attached to the supply can not be prevented or services offered on the market. (2) The following CE mark is not attached to the device and can not be any obstacles for these situations:
a) comply with the requirements in Annex VIII and Article 15 of devices for clinical research, medical practitioner or clinical research making use by authorized persons,
b) Annex VIII is mentioned declaration has to be provided that these regulations according to custom-made medical devices by name or identification number with a particular II patients Class offered the use of, IIb and III they offered medical devices to the market and service.
(3) provisions of this Regulation to non-conforming medical devices, can not be marketed until fulfilled Regulation and services can not be provided with a mark bear record shows clearly, places notation as trade fairs and exhibitions inevitable.
(4) Annex I (13) to patients specified by the number of and the manufacturer, information to be given to users and practitioners with the medical device, user manuals, labels, maintenance booklet and other disclosures must be Turkish When medical devices placed on the market.