Products of companies lacking MDR compliance removed from UTS: 'Only one or two suppliers left'

Turkey has transitioned to a new system for medical devices and consumables. The new Medical Device Regulation (MDR), published by the European Union in 2017 and implemented in 2020, has also been put into effect in Turkey. Following the transition period, the additional time granted to companies requesting extensions has also expired. The Ministry of Health's Turkish Medicines and Medical Devices Agency has removed the products of non-compliant companies from the Product Tracking System (UTS). As of the end of August, the Social Security Institution (SGK) also announced that, in accordance with legislation, it would not pay for devices that are not in the UTS.

According to the report by Mehmet Kaya from Ekonomim, it is emphasized that around 178 thousand products have been removed from the system. According to information obtained, objections have been filed regarding 11 thousand of these. Although the number may seem high at first glance, medical devices technically define a very wide range of products, starting from the simplest clips or needles.

This development in the sector is a result of companies choosing not to comply due to costs or other reasons.

ONLY ONE SUPPLIER LEFT FOR MORE THAN 1000 PRODUCTS

On the other hand, concerns about a loss of competition have also emerged. No strong concern has yet been reflected to either the public or the sector's non-governmental organizations. However, industry NGOs held a meeting with Social Security Institution officials to evaluate the process. The main topic was that only one or two suppliers remain for some medical devices and that this could create a serious competition problem. Some industry representatives had expressed views that only one or two suppliers remained for more than 1000 products. In their review, SGK officials conveyed the view that the number of products with only one or two suppliers remaining is much lower and that there will be no loss of competition for the sector. Industry representatives also emphasized to EKONOMİ that there is currently no visible problem with access to devices, but that the sector is in a sensitive period.

Sector officials underlined that although the MDR compliance process is ongoing and there is no obstacle for companies removed from the list to be included in the UTS again—and thus in the SGK procurement system—the fact that approximately 25-30 percent of the total product supply has been removed from the list is a significant development. On the other hand, when looking at it on a code basis, they stated that along with previous UTS removals, there appears to be one supplier for 600 codes and two suppliers for 500 codes.

Beyond this, it was emphasized that it is noteworthy that the SGK also performed a removal process from the system, which would lead to an additional workload, and did not issue a warning to the sector, even though there is no possibility of sales in the SGK system due to the removal from the UTS. It was noted that it would be beneficial to develop a support mechanism for compliance with the MDR, which is the main factor in the emergence of the current situation, especially for domestic manufacturers.

'NO GENERAL CONCERN OBSERVED'

The issue was evaluated at a meeting held at the SGK the other day, which was also attended by industry representatives. It was learned that the public side gave the message that the number of products that have fallen to one or two suppliers is very low, that there is no situation that would violate competition, but that they are following the issue with sensitivity. It was conveyed that there are other products of equivalent quality for the products on the lists that have fallen to a single supplier. Again, looking at the lists in general, they stated that they do not see any warning signs regarding access to medical devices and materials. Industry NGOs also emphasized that for now, there are no question marks regarding supply and that no general concern is observed.

They also underlined that the process of compliance with the regulation is at the initiative of the companies. Meanwhile, it was stated that the problems experienced in previous years due to public payments being made very late have not been fully resolved, but that the public is making an effort to make payments regular, even if there are long maturities.

News Source: 12punto