FDAnews Device Daily Bulletin
Medical Devices / Regulatory Affairs

MedTech Europe Calls for Building Blocks to Implement EU Regs On-Time

Dec. 5, 2017

EU authorities must take swift action on three essential building blocks to implement the new regulations for medical devices and in vitro diagnostics smoothly and on-time, MedTech Europe said in three new position papers.

The trade association called on the European Commission to invest more resources, to ensure the capacity and availability of notified bodies, and to ensure a consistent interpretation of the transition periods — three years for medical devices and five for IVDs.

Ultimately, the goal is to prevent disruption to product availability during the transition periods, the industry group said.

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