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Medical Devices (EU) Regulation Study

 

Dear Member,

In a letter received by our Chamber from the Union of Chambers and Commodity Exchanges of Turkey, it is stated that the European Commission has conducted a consultation process regarding the (EU) Regulation 2017/745 on Medical Devices (MDR) and the (EU) Regulation 2017/746 on In Vitro Diagnostic Medical Devices (IVDR), adopted in 2017. Following the evaluations obtained during this consultation process, the Commission prepared a draft Regulation proposal, and the evaluation report and summary, along with the draft Regulation proposal and working paper documents, have been published. 

In this context, detailed information regarding the feedback process on the draft Regulation can be accessed via the link below, and comments can be submitted between January 7th and March 11th, 2026.

Details can be found at the following link: https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/14808-Medical-devices-and-in-vitro-diagnostics-targeted-revision-of-EU-rules_en. Please send your comments to (rezzan@gso.org.tr).

For your information.