Silver-coated Devices in Turkey Will Require EC Certificate of Conformity

Posted 13 January 2014 | By

Turkey's Pharmaceutical and Medical Device National Databank, TITUBB, issued a notice on 10 January 2014 that as of 30 June 2014, medical devices with anti-bacterial silver coating will be only accepted for registration in Turkey when accompanied with an European Commission (EC) Certificate of Conformity.

The decision follows the issuance by the EU in June 2013 of a clarification concerning the classification of such devices as Class III, which requires the devices to comply with conformity assessment procedures.  The EU clarification applies to devices where the silver coating is intended to serve as an anti-microbial agent.


TITUBB Announcement

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