There’s much uncertainty and concern about the new IVD Regulation in Europe. The new regulations began this past European holiday weekend, and begin a lengthy transition to implementation. If you are wondering how this may work out, look Down Under, where at the end of June, Australia will complete its transition to new IVD Regulations (IVDR). We take a look at the lessons to learn from the Australian experience.
The European Union finally agreed late Wednesday Brussels time on a final text for the long awaited European Device regulations. Agreement of course is subject to approval by other players in the EU political process, but it does look as though we are reaching the end of the journey in the long awaited updates to the MDD/AIMD/IVDD Directives. The long telegraphed increases in rigour of inspection, post market monitoring and unannounced inspections are all included.