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IVD manufacturers cite the new classification system, detailed definitions for intended purposes, and the need for verification of clinical evidence as key challenges under the IVDR.
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On October 23, the European Parliament adopted a resolution revising specific elements of the Medical Devices Regulation (MDR) and the In Vitro Diagnostic Devices Regulation (IVDR). This resolution intends to address ongoing challenges in implementing the regulations by 2025 and to improve patient access to important medical products.
Multilingual documentation presents ongoing compliance and logistical hurdles for MedTech manufacturers. Transla.Ai is an industry-specific translation tool that can accelerate and streamline the translation process.
The connection between supplier controls and business risks is becoming increasingly evident. In this article, we discuss perspectives on how to maintain a compliant medical device supply chain.
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