Turkey’s Medical Device Agency Warns about Void Conformity Certificates in Pandemic Times

Turkish Medicines and Medical Devices Agency (“TITCK”) has recently announced that documents by means of conformity certificates issued by both local and foreign institutions especially during COVID-19 pandemic times are void pursuant to regulations concerning medical devices in Turkey. TITCK adds that, documents are mostly issued for products such as non-sterile medical masks and aprons having the titles of ‘Certificate of Compliance’, ‘Attestation of Compliance’, ‘Certificate of Conformity’, ‘Certificate of Notification’, ‘Certificate of Registration’, ‘Documentation Review’ or similar.

Medical devices are regulated by Regulation on Medical Devices, Regulation on Active Implantable Medical Devices and Regulation on in vitro Diagnostic Medical Devices in Turkey. Pursuant to those, prior to placing a medical device on the market, such device should be assessed and affixed “CE marking”.

In this regard, for moderate and high-risk medical devices, conformity assessment procedures involve the intervention of a third party notified body. However, Class I medical devices which are non-sterile and do not have a measuring function under the Regulation on Medical Devices and, also the devices categorized as “Other” under the Regulation on in vitro Diagnostic Medical Devices are deemed low-risk devices. To place such low-risk medical devices on the market, the manufacturer shall draw up a “Declaration of Conformity” and prepare a medical file as regulated under the relevant legislation in order to affix the CE marking. In other words, for such low-risk medical devices conformity assessment procedures do not require the intervention of a third party notified body.

TITCK highlights that certificate usually issued by certification institutions and testing laboratories regarding conformity to medical device regulations or applicable standards are not accepted as conformity declaration of the manufacturer or CE marking affixed pursuant to a notified body assessment pursuant to the relevant legislation.

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