Union of Chambers and Commodity Exchanges of Turkey

Information Panel on Medical Device Regulation held at TOBB


09.11.2023 / 



The Medical Device Regulation (MDR) Information Panel was hosted by the Union of Chambers and Commodity Exchanges of Türkiye (TOBB) Medical Council in Ankara with the participation of TOBB Board Member Seyit Ardıç, Turkish Pharmaceuticals and Medical Devices Agency (TİTCK) Officials, Turkish Standards Institute (TSE) Officials, Ministry of Trade General Directorate of Export Officials, non-governmental organizations and private sector representatives from various cities.​

Opening speeches were made by TOBB Board Member Seyit Ardıç and TOBB Türkiye Medical Council President Levent Mete Özgürbüz, and the Medical Device Regulation (MDR) was evaluated by TİTCK, TSE and the Ministry of Trade.

In his opening speech, Council President Levent Mete Özgürbüz mentioned the importance of the Medical Device Regulation for the sector and stated that CE certificates will contribute to the development of the sector.

TOBB Board Member Seyit Ardıç stated that the transition process to the Medical Device Regulation should be evaluated in the best way possible in order to manage the transition process for the medical sector without any problems in supply and without compromising service quality.

In the first session of the panel, moderated by Fatih Topuz, Head of the Medical Device Notified Body and Clinical Trials Department of TÄ°TCK, and with the participation of panelists consisting of TÄ°TCK representatives, the topics of innovations introduced by the MDR, MDR transition process, extension of MDD document periods, clinical trial processes, traceability and registration of medical devices were discussed.

In the second session, moderated by Sezai DoÄŸan, Head of TSE Product Certification Group, TSE representatives evaluated the Medical Device Regulation under the headings of transition process, clinical evaluation process in the eyes of notified body, medical device technical documentation, biocompatibility and quality management system.

The Panel ended after the representative of the Ministry of Trade explained the supports for the sector.

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