Regulation (EU) 2017/746 on In Vitro Diagnostic (IVDR)

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Regulation (EU) 2017/746 (IVDR) sets a new milestone in the regulation of in vitro diagnostic medical devices. With 113 articles and 15 annexes, the IVDR may create new regulatory challenges for IVD manufacturers. The IVDR requires in vitro diagnostic manufacturers to completely revise their quality management system and technical documentation for all products. New processes must be implemented to meet the increasing requirements. Topics such as Unique Device Identification, Performance Evaluation or Post-Market Surveillance are just a few examples of a multitude of changes in the medical device industry. Let our team of former regulators help you establish, audit or remediate your quality systems. Our experts can help you prepare for market, mitigate risk, and comply with country-specific regulations and international standards. We can assist you with training, consulting, technical document preparation, technical document remediation, performance evaluation reports, and more.
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