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Take Timely Steps To Alleviate Upcoming IVDR Compliance Woes

Non-Negotiable: Compliance With EU Diagnostics Regulation Must be Planned In

 
• By Ashley Yeo

The transition periods for complying with the EU’s In Vitro diagnostics medical devices regulation might have been extended, but that does not change the scale of the compliance task at hand for manufacturers, says digital labeling provider Kallik.

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Over 80% of devices that did not require certification under the EU’s In Vitro Diagnostic Directive (IVDD) will now require certification under the superseding regulatory instrument, the In Vitro Diagnostics Regulation (IVDR).

Enhanced certification requirements will affect quality management, device traceability and device packaging, among other things. Product labeling and artwork for...

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