NoBoCap: Notified Bodies Want To Deliver More Transparency And Predictability

Start-ups And SMEs Are Underprepared - Through No Fault Of Their Own

Speakers focused on whose role it is in the EU to support manufacturers who struggle to interpret the medtech regulations.

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The current level of inconsistency in the interpretation of the EU’s Medical Device and IVD Regulations, which has lead to a continued avalanche of guidance, is a major factor in generating the need for more support for manufacturers.

Key Takeaways

Inconsistency in the interpretation of the EU’s Medical Device and IVD Regulations is leading to a crucial need for more support for manufacturers.

Notified bodies are unsure of where to draw the line between permissible dialogue with manufacturers, and forbidden consultancy

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