Global Medtech Guidance Tracker: May 2022
Executive Summary
Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Forty-two documents have been posted on the tracker since its last update.
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No MRA Means Switzerland’s Seamless IVDs Trade With The EU Is At An End
The EU’s full implementation of the In Vitro Diagnostic Regulation on 26 May has put the Swiss IVD industry on a "third country" footing with the EU, as happened in 2021 for medical devices. The two parties’ mutual recognition agreement for all medtech products has ceased to apply. A renewed MRA is not likely for several years.
FDA Draft Guidance Would Set In Stone Case For Quality Voluntary Improvement Program
The draft document from the US agency looks to officially recognize a program aimed at advancing quality in medical devices and their manufacturing.
UK’s Revamped Clinical Trials Framework To Offer Faster Application Review Timelines Than EU
The UK has finalized plans for delivering what it believes will be a stable and streamlined clinical trials framework following its departure from the EU. Transparency, patient involvement and diversity are high on the agenda.