medical devices

New publication from the OrphaDev4Kids project

New publication from the OrphaDev4Kids project

A new scientific publication has been published in the journal Frontiers in Medicine, contributing to the advancement of innovation in orphan medical devices for paediatric populations. The article, titled “Clinical perspectives on wearable devices for pediatric...

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EU issues new guidance on orphan medical devices

EU issues new guidance on orphan medical devices

The European Commission has released new guidance, namely “Clinical evaluation of orphan medical devices”, aimed at facilitating the clinical evaluation of orphan medical devices. Orphan devices are designed to treat rare diseases affecting no more than 12,000...

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Key changes in medical device regulation in the EU

Key changes in medical device regulation in the EU

Regulation (EU) 2017/745 on medical devices becomes applicable in the European Union. It aims to ensure the smooth functioning of the internal market as regards medical devices, for a high-level protection of health for patients and users.

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