The first Turkish notified body has been designated under the EU’s Medical Device Regulation.
Notice Belgelendirme, Muayene ve Denetim Hizmetleri Anonim Şirketi, based in Istanbul, was formerly designated under the Medical Devices Directive (MDD)...
Turkey may not be part of the EU, but its customs agreement with the bloc enables it to designate notified bodies under the EU’s Medical Device and IVD Regulations. The first such designation has just been announced.

The first Turkish notified body has been designated under the EU’s Medical Device Regulation.
Notice Belgelendirme, Muayene ve Denetim Hizmetleri Anonim Şirketi, based in Istanbul, was formerly designated under the Medical Devices Directive (MDD)...
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TRiCares announced first implantation of the Topaz transfemoral tricuspid heart valve replacement system as part of the company’s EU pivotal study. If all goes to plan, the device will compete with Edwards’ Evoque system. The announcement follows the company’s $50m series D funding raise in July.
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The US FDA has published a trio of draft guidance documents for its Assessment Scheme for Conformity Program, which began as a pilot in September 2020 to capitalize on the role of standards in the regulation of medical devices.
The US FDA has published a trio of draft guidance documents for its Assessment Scheme for Conformity Program, which began as a pilot in September 2020 to capitalize on the role of standards in the regulation of medical devices.
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