Belgium Allows Reprocessing Of Single Use Devices And Relaxes In-House Manufacture Rules
Executive Summary
The shortage of medical equipment to manage the COVID-19 pandemic is leading many countries to take measures to allow unregulated devices onto the market. Belgium is creating its own solutions.
You may also be interested in...
EU’s COVID-19 IVD Guidelines Reflect Need For Nuanced Approach To Testing For Member States
New European Commission guidelines on COVID-19 IVD tests and their performance not only explain the regulatory requirements, but also detail why different levels of precision may be acceptable in different contexts.
EU Regulatory Experts Support Notified Bodies, But Argue For Greater Consistency
Notified bodies have been a pivotal part of the EU medtech regulatory system since it was first launched in the 1990s. Where might they fit within a new medtech regulatory governance structure? Panelists on a recent vodcast grappled with the question.
First Public Discussion On How EU Medtech Regulatory Governance Structure May Evolve
Does the EU need a medtech agency for the first time in its history? Nothing can or should be decided too quickly but five high-profile experts broadly agreed that change is now critical.