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Guidance on the Health Institution Exemption Under Article 5(5) of EU MDR and EU IVDR

Feb 2, 2023 | News

In-house medical devices are exempted from most of the provisions of (EU) 2017/745 (Medical Devices Regulation) and (EU) 2017/746 (In Vitro Diagnostic Medical Devices Regulation), given that the health institution follows the conditions laid out in Article 5(5) of the...

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