Essentials of European Medical Device Regulatory Affairs - October 2019

GSPRs General Safety and Performance Requirements

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Submit to NB if required

• Considerations for choosing a NB: – Are they designated under the MDR? – Do they have the right scope? – Is my NB sustainable? Multisite? Resource? Brexit? – Can I work with these people? – Do these people understand my technology? – Do we share: testing, validation & clinical approach? – Will their reputation enhance mine? – Will there be language issues? – What is the time and cost – will quotes hold? – Consider who your contractors and competitors use • Factor into your product launch plans!

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