Union of Chambers and Commodity Exchanges of Turkey

TOBB Türkiye Medical Council meeting was held under the chairmanship of Levent Mete Özgürbüz, President of the Sector Council with the participation of TOBB Vice President S. Zeki Murzioğlu, TİTCK President Asım Hocaoğlu and TİTCK Vice President Mehmet Hakan Fırat.

At the meeting held in Ankara, the obligations of the Medical Device Regulation (MDR), which will enter into force in May 2024, were discussed. At the meeting, it was pointed out that the time foreseen for the transition to the MDR is shrinking, and it was stated that TOBB and TÄ°TCK are providing the sector with all the support it needs.

In his speech at the opening of the meeting, TOBB Vice President S. Zeki MurzioÄŸlu stated that they are ready to provide all kinds of support to improve cooperation during the transition to the Medical Device Regulation (MDR). MurzioÄŸlu reminded that the obligations regarding the MDR Regulation within the scope of EU harmonization should be fulfilled as soon as possible in order to prevent the sector from experiencing problems in the future.

Asım Hocaoğlu, President of TİTCK, stated that it is important that there are no problems in procurement and that the transition period should be evaluated in the best way in order to continue activities without compromising service quality. Mr. Hocaoğlu underlined that they are ready to provide all kinds of support to the sector in this regard. Asking for the necessary sensitivity to be shown due to the short time remaining in the transition process from MDD to MDR, Mr. Hocaoğlu expressed his expectations from the sector representatives on the subject.

- Attention to these dates for document extension

Ömer Faruk Kuru, Head of the Medical Device Registration and Coordination Department of the TİTCK, made a presentation on the document extension for the transition to MDR; and stated that in order to benefit from the document extension, manufacturers with a valid EC Certificate must apply to a notified body appointed within the scope of MDR until 26.05.2024 and a contract must be signed with the notified body until 26.09.2024. Ömer Faruk Kuru mentioned the common mistakes made in time extension applications and expressed his warnings on this issue.

At the meeting, it was announced that a webinar will be held on January 19, 2024 with the participation of all sector representatives regarding the obligations of the MDR, which will enter into force in May 2024.