FDAnews Device Daily Bulletin
Medical Devices / Regulatory Affairs

EMA Publishes Draft Guidance on Combo Device Quality Req’s

June 4, 2019
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The European Medicines Agency (EMA) has issued a draft guideline on quality requirements for combination devices, opening the guidance up to a three month public consultation.

The guideline, which applies to devices required for administering, dosing or using medications, is meant to improve the consistency and transparency of information included in their regulatory submissions.

Specifically, it details device information sponsors need to include in their initial marketing authorization applications and during their products’ lifecycle.

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