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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...

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

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

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