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How EU's Competent Authority Group Is Flexing Its Muscles For New Roles

Executive Summary

What do we know about the EU's Competent Authorities for Medical Devices group? It will have an important role in the implementation of the EU's new Regulations and in managing an EU market-surveillance project.

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EU Implementation Plan For New Regs Starts To Take Shape

The European Commission and competent authorities are now putting together an implementation roadmap that will change the face of medical device and IVD oversight across the region. Medtech industry representatives and other stakeholders weighed in on priorities during a March 9 meeting. More details on the implementation roadmap for the Medical Device and IVD Regulations can be expected in June.

EU Market Surveillance: It’s About Rationalizing Resources, Not Seismic Changes

The EU’s joint action on market surveillance, now a focus after the success of the joint action on notified bodies, is focusing on cooperation and avoiding duplication, rather than a step change, to achieve a safe EU. But it is early days and the key changes that will ultimately impact manufacturers will be announced further down the line.

Will EU’s New Market Surveillance Project Hit As Hard As Notified Body Action?

With control having been radically tightened over EU notified bodies over the last three years, it is possible manufacturers can expect an equally tough change for market surveillance now that competent authorities are putting together a major action plan for the activity.





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