What Is the EC Certificate Required for UTS?

What Is the EC Certificate Required for UTS?

In the Turkish UTS (Product Tracking System) context, the EC certificate is the CE certificate issued by an EU notified body under the relevant medical device directive or, more recently, the Medical Device Regulation. Devices subject to the Turkish medical device regulations (which transpose the EU rules) must carry a valid EC certificate and a matching declaration of conformity before they can be sold or registered in UTS.

Why the EC Certificate Is Central to UTS

UTS is the record layer above conformity assessment. If the device does not have a valid EC certificate, there is nothing for UTS to record. If the certificate lapses, the UTS record must reflect that, and the device cannot be distributed further until the certificate is reissued.

Step 1: Identify the Correct Directive or Regulation

Before applying for an EC certificate, the manufacturer identifies which medical device framework the device falls under: general medical devices, active implantable medical devices, or in vitro diagnostic medical devices. Each framework prescribes its own conformity assessment routes, clinical evidence requirements, and post-market obligations.

Step 2: Determine the Risk Class

Risk classification (Class I, IIa, IIb, III for general medical devices) drives the conformity assessment route. A Class I non-sterile, non-measuring device can self-declare conformity, while a Class III implant requires design dossier review by a notified body. The technical file, clinical evaluation, and quality system requirements all scale with risk class.

Step 3: Notified Body Assessment

For all classes above the lowest, a notified body assesses the quality management system (typically against ISO 13485) and the product technical file. Once the assessment is successful, the notified body issues the EC certificate that feeds into the UTS record.

How Sistem Patent Kalite Helps

Sistem Patent Kalite supports manufacturers on both sides of the process: preparing the technical file, clinical evaluation, and ISO 13485 quality system for the notified body, and then entering the issued EC certificate into the UTS database with the correct product, scope, and signatory records.

Contact Us

For EC certificate planning for UTS, or for any medical device regulatory question, contact our specialists.