Dicle Doğan and Fatma Sevde Tan, Gun + Partners
On 1 July 2020, the Turkish Medicines and Medical Devices Agency published an announcement (Turkish language) stating that declarations of conformity for medical devices issued by organisations other than manufacturers have no validity. Declarations of conformity can only be issued by manufacturers.
Products classified under the Turkish Medical Devices Regulation as Class I (non-sterile and non-measuring) products and under the "Other" category within the scope of the Turkish In Vitro Medical Diagnostic Devices Regulation are defined as "low-risk" medical devices. In order for those medical devices to be placed on the market, approval from notified bodies is not required. For low-risk medical devices, it is sufficient for manufacturers to issue a declaration of conformity and prepare a technical file as specified by the relevant legislation.
However, especially during the COVID-19 pandemic period, various organisations submitted documents under different names in relation to non-sterile medical masks, gowns and other similar Class I products to the Agency. The Agency therefore published an announcement highlighting the invalidity of declarations of conformity issued by non-manufacturers.
First published by Practical Law in Aug 01, 2020.