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Comprehensive commentary on Regulation (EU) 2017/745 on medical devices is published


The publication contains both the necessary interpretative statements based on the European MDCG documents and, above all, practical guidance on how to meet the wide range of new requirements. Almost 800 standard pages of text are supplemented by clear infographics (process maps, flow charts, tables, etc.), commentary on all articles of the regulation as well as all its annexes.

It will be especially appreciated by domestic manufacturers, importers and distributors of medical devices, as well as notified bodies, hospitals, pharmacies and medical device dispensers.

The publication is published by Porta Medica, co-published by the Czech Agency for Standardization. If you are interested, you can order the commentary now at a discounted price in the pre-sale via the Erudikum e-shop, which distributes the here (available in Czech language only).

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