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One Hurdle After Another: Safely Aligned With EU MDR, Turkish Medtechs Brace For New Efforts On Domestic Front

09 Jun 2021

• By Ahmet Sevindik

Alignment with the MDR gave Turkish medtech access to the EU market, but in domestic pricing, costs, reimbursement and payment of hospital debts, industry might feel it is barely at the starting line.

To great relief locally, the problem of aligning Turkish medtech regulation with EU Medical Device Regulation was finally solved. The Turkish government published the newly-adopted MDR regulation in the Official Gazette, making it law.

Had the issue turned into a full-blown crisis, it could have jeopardized the local industry’s annual $1bn exports to EU. Some 1,500 companies in Turkey export CE marked products to...