New NB designated under EU MDR / IvDO SR 812.219 update


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Please find below the latest regulatory news in Europe.

IvDO SR 812.219 (IvDV):

The Federal Council of Switzerland also has published on 1. November 2023 the updated IvDO which is related to medical devices in Switzerland.

Link to IvDO

Notified Body NB_2764 designated according to EU MDR 2017/745:

With Notified Body Notice Belgelendirme, Muayene ve Denetim Hizmetleri Anonim Şirketi from Türkiye now 40 NB's are designated according to EU MDR.

Link to the scope document

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We provide consistent updates about regulations and guidelines in the European Medical Device and In-Vitro Diagnositc Industry.

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