EU
The document outlines the approach to be followed in order to ensure standardisation for medical devices, facilitating further harmonisation of the relevant regulatory requirements.
EU
The new article describes in detail the relevant harmonised standards applicable to medical devices, and also the way they should be applied.
EU
The new article describes in detail the approach to be applied when it comes to the re-assessment of designation under the new regulatory framework.
EU
The new article highlights certain specific aspects associated with designation, such as notification procedure or changes to the scope of designation.
EU
The new article clarifies the aspects associated with the designation decision to be taken with respect to the applicant entity in the context of the CAB/NB designation process.
EU
The article provides a general overview of the existing legal framework for special authorized bodies undertaking special functions with respect to medical devices.
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