Many medical devices that fully comply with the European Union Medical Device Regulation (MDR) encounter unexpected disruptions after entering the Turkish market. In some cases, products are suddenly withdrawn from sale or assigned a “rejected” status within the Product Tracking System (ÜTS).
This situation is often surprising for manufacturers, as the device is technically MDR-compliant and continues to be marketed without issue within the European Union.
So where does the problem actually begin?
This article provides clear, practice-based answers to five key questions most frequently raised by European manufacturers operating in or entering the Turkish medical device market.
In Turkey, the continued market presence of a medical device is not guaranteed solely by MDR compliance. Commercial continuity depends on the integrity and consistency of the product’s registration within the Product Tracking System (ÜTS).
ÜTS does not assess devices solely on the basis of whether regulatory documentation exists. Instead, the system requires full and simultaneous alignment between multiple elements, including:
EC certificate
Declaration of conformity
Manufacturer information
Product classification
Importer linkage
Certificate validity status
If any of these elements are outdated, inconsistent or incorrectly reflected in the system, the product may be rejected without any warning period. Even if the device remains technically safe and compliant, commercial activity may come to an immediate halt.
In most cases, the issue does not stem from the absence of documentation, but from the way EC certificates and related records are reflected within ÜTS.
The following situations frequently create critical risks:
A change in EC certificate number following MDR transition
A change of Notified Body
Minor revisions to the EC certificate
Expansion or limitation of the certificate scope
Such changes are often regarded as minor or purely administrative by manufacturers. However, ÜTS does not tolerate undocumented or misaligned revisions. Even small discrepancies may result in system-level rejection.
The outcome is a device that is MDR-compliant in principle, yet incompatible with the operational requirements of ÜTS.
ÜTS functions as the operational core of the Turkish medical device market. Product sales, stock movements, tender participation and reimbursement processes are all directly linked to this system.
Key characteristics of ÜTS include:
No manual tolerance mechanisms
No revision or transition periods
No acceptance of provisional compliance
Strict one-to-one alignment between product, documentation and importer
For this reason, ÜTS should not be regarded as a simple registration platform. It represents a central risk factor that directly affects commercial continuity.
Yes. In practice, importer-related errors represent one of the most significant risk factors for manufacturers in Turkey.
Although importers are responsible for executing ÜTS registrations, any error or omission within the system directly affects the manufacturer’s product. Such issues may result in suspended sales and reputational damage.
In many cases, manufacturers only become aware of the problem once the product status in ÜTS changes to “rejected”. Until that point, no advance notification is issued by the system.
For this reason, structured and continuous communication between manufacturer and importer is not optional in Turkey. It is a strategic necessity.
In theory, control remains with the manufacturer. In practice, however, it is shaped by the interaction between regulatory systems and local operational processes.
Control in the Turkish market is effectively distributed across three parties:
The manufacturer, responsible for documentation and technical compliance
The importer, responsible for registration and operational execution
ÜTS, acting as the final decision-making authority
Without continuous and technically informed coordination between these parties, regulatory and commercial risks become unavoidable. Following MDR transition, lack of coordination has emerged as one of the most common reasons for products being withdrawn from the Turkish market.
The Turkish medical device market may be smaller in volume compared to the European Union, but it requires a high level of regulatory precision and operational discipline.
MDR compliance alone is not sufficient. EC certificates, ÜTS registrations and importer processes must be managed simultaneously and on an ongoing basis. Even minor inconsistencies between documentation and system records may lead to immediate commercial disruption.
In this context, alignment with European regulatory best practices, including guidance issued by industry bodies such as MedTech Europe, plays a critical role. These guidelines emphasise transparency, traceability, clear allocation of responsibilities and continuous oversight throughout the product lifecycle. While such principles are well established at EU level, their practical implementation at national system level requires careful adaptation.
What ultimately makes the difference is not merely knowledge of the regulations, but a structured, guideline-oriented approach that reflects how regulatory systems function in practice within Turkey. This perspective is essential for manufacturers seeking long-term continuity and risk-controlled access to the Turkish market.
