Medical Device Regulatory Services
in Turkey
 

Overview

The Turkish medical device market has seen significant and consistent growth over the past decade. In 2021, Turkey adopted the EU Medical Devices Regulation (MDR) 2017/745 and In Vitro Diagnostics Medical Devices Regulation (IVDR) 2017/746. This enhanced international trade leading several global companies to launch their medical devices in the country.

Regulatory Authority: Turkish Medicines and Medical Devices Agency (TITCK)

Regulation: Medical Device Regulations (MDR) 2017/745, In Vitro Diagnostic Devices Regulations 2017/746

Regulatory Pathway: CE marking is mandatory followed by Registration/Notification in the Product Tracking System (UTS)

Authorized Representative: European Authorized Representative (EAR) for foreign (non-EU/non-Turkey) manufacturers

QMS Requirement: ISO 13485:2016

Assessment of Technical Data:  Notified Body for CE marking

Validity of License: Unlimited

Submission Format: Paper

Translation: Translated Documents in Turkish

Device Classification

Turkey follows the same medical device classification as given in the EU MDR and IVDR. Determining the device classification can be challenging and hence having backed by an experienced regulatory consultant is quite crucial here.

Medical Device Classes -

Class

Risk

Class I

Low

Class IIa

Moderate

Class IIb

Moderate to High

Class III

High

In Vitro Diagnostic Device Classes -  

Class

Risk

Class A

Low

Class B

Moderate

Class C

Moderate to High

Class D

High

European Authorised Representative (EAR)

Now, due to the custom union agreement, the EU manufacturers do not require to appoint a local authorised representative to place their devices in the market.

Other foreign manufacturers are required to appoint a European Authorised Representative (EAR) to place the devices in the Turkey market.

Medical Device Registration

CE marking is a conformity that is required by the manufacturers to place their device in the Turkey market. CE marking is issued through a conformity assessment carried out by the notified body. Now, Turkey is authorised to appoint notified bodies in accordance with EU MDR and IVDR.

The companies are required to register in Central Registration System (MERSIS) registration and register the device in the Product Tracking System (UTS).

Process flow

Post-approval Device Lifecycle Management

Freyr supports foreign manufacturers in end-to-end Medical Device lifecycle management, including post-approval activities, such as:

  • Post approval change management - modifications to existing medical device approvals such as the addition of new variants, accessories; addition of new indications of use among others
  • Maintenance of ISO 13485:2016 and CE certification
  • Renewal of licenses
  • Liaising between Notified body and the manufacturer

With various authorization bodies involved, foreign manufacturers need to comply with multiple sets of regulations in each individual process for device approvals. Obtaining a CE marking and further adhering to state-wise regulations needs extensive Regulatory knowledge. At times, without a proven Regulatory partner, navigating through all the device requirements might be challenging for market entrants. To assist manufacturers, Freyr provides end-to-end Regulatory services to expedite approvals for medical devices.

Expertise

Freyr Expertise