Today is the day that the amendment, aka the ‘extension’, to the MDR enters into force because it was published in the EU’s Official Journal today, number L080. As you are reading this, the amendment now applies all throughout the Union as referenced in article 1 MDR and IVDR. Union as in not European Union, which is something different. This is one of the most often made mistakes in relation to the application of the MDR and IVDR: people (among which even the MDCG in some cases, such in as MDCG [...]
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