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Italy | In vitro diagnostic medical devices, designation of EU reference laboratories

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The European Commission has the possibility to designate one or more European Union Reference Laboratories - EURLs for devices or for a specific category or group of devices, or for specific risks related to a category or group of devices.

The laboratories that can be designated must meet the criteria indicated in paragraph 4 of article 100 of Regulation (EU) 2017/746 .

The European Commission can designate, by means of implementing acts, only laboratories for which a Member State has submitted an application for designation .


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