UTS Certificate Renewal for Medical Devices

When a CE Certificate Is Renewed, the UTS Record Must Be Updated

Medical devices sold in Turkey and in the European Union fall under the CE marking obligation set by the EU medical device directives and the Turkish regulations that transpose them. The manufacturer's CE certificate is not a one-time approval. Depending on the directive and the product risk class, the notified body conducts surveillance and reassessment cycles at defined intervals, and the certificate is reissued once the requirements are met again.

Every time a CE certificate is reissued, the Product Tracking System (UTS in Turkish, run by the Turkish Ministry of Health) must be updated with the new document. The old certificate record remains historical, and the new certificate becomes the active reference that supply-chain actors, importers, and distributors rely on.

What Gets Updated in UTS

A UTS certificate renewal is not limited to uploading the new PDF. The following product documents must be reviewed and, where changed, updated in parallel:

• The reissued CE certificate and its declaration of conformity
• The instructions for use (IFU) if the manufacturer has revised them
• The technical file sections affected by the reassessment
• The product labelling and any brand or packaging changes
• Turkish-language versions of documents that are not originally in Turkish

Who Is Responsible

The legal manufacturer, the authorised representative in Turkey, and the authorised UTS user (signing with an electronic signature) share responsibility for keeping the record current. If the CE certificate lapses because the UTS update is late, the device can be blocked from sale and from hospital tender submissions, which is a commercial risk far greater than the renewal itself.

How Sistem Patent Kalite Helps

Sistem Patent Kalite has served Turkish and international clients since 1999. Our UTS team reviews the old and new CE certificates side by side, checks what has changed in scope, IFU, and labelling, prepares the Turkish translations, and enters the updated record in UTS so the certificate remains valid without a gap in the database.

Get in Touch

For a UTS certificate renewal, or for any question about the Product Tracking System workflow, contact our specialists.