QUOTED. Jan. 15, 2018. Oliver Bisazza.
Executive Summary
Check out what MedTech Europe's Oliver Bisazza had to say about how long it will take for notified bodies to become approved under the EU's Medical Device and IVD Regulations.
"We’ve been told that much of Q1 2018 will be spent simply reviewing the [paper] applications notified bodies start submitting, with onsite assessments starting in Q2 2018. We would like to see more ambitious timelines attempted." –Oliver Bisazza, director of regulations and industrial policy, MedTech Europe
> Find out more: EU Regulatory Reads, 2017: Are We Heading Toward A 2018 Crisis?
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