The Routes To Conformity - Navigating EU Regulation

Conformity Assessment Procedure for Medical Device under the Responsible Model (EU MDR 2017/745 & EU IVDR 2017/746). A medical device manufacturer has to follow Conformity Assessment Procedure before placing the device on the EU Market. These conformity assessment procedures are documented in Article 52 of the EU MDR 2017/745 for Medical Devices & Article 48 of EU IVDR 2017/746 for Invitro Diagnostic Medical Device.

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ConformityAssessmentRoutes
EURegulation
EUMedicalDevice
EUMDR
EUIVDR
EUInvitroDiagnosticMedicalDevice

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