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The IVDR is the new regulatory basis for in vitro diagnostic medical devices to be available on the European market. This will replace the EU’s current In Vitro Diagnostic Directive 98/79/EC (IVDD) on in vitro diagnostic medical devices. This new regulation will affect all EU member states and EFTA states immediately without needing to be transferred into the law of respective states, however national laws may be adapted to back some requirements in greater detail.
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Bosnia and Herzegovina