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.
You may also be interested in...
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FDA Draft Guidance Would Set In Stone Case For Quality Voluntary Improvement Program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.
Evusheld: UK Urged To Use RWD To Give Clinically Vulnerable Early Access To COVID-19 Treatment
A full appraisal by the UK cost watchdog is not the only way to gauge the safety and effectiveness of Evusheld, argues the independent Drug Safety Research Unit in response to the government’s decision not to buy the licensed COVID-19 drug because of insufficient data on protection.