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Home › Business, Policy & Funding › Regulatory News & FDA Approvals › EMA Issues Guidance Related to New European Medical Device, IVD Regulations

EMA Issues Guidance Related to New European Medical Device, IVD Regulations

Mar 01, 2019
|
staff reporter

NEW YORK (360Dx) — The European Medicines Agency this week published its first guidance to help test makers bring their products into compliance with new regulations.

The guidance is the first of several that will cover the new medical device regulation (MDR) and in vitro diagnostic regulation (IVDR), which are set to come into force by 2020 and 2022, respectively.

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