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How The Right Operating Model For EU MDR Compliance Can Support A Global Footprint

A Cost-Effective Approach To EU MDR Compliance

Combination Product QMS Requirements For Pharma Companies Entering The EU Market

EU MDR Now Regulates Beauty Devices As Medical Devices

The EU Regulation 745/2017 on medical devices (EU MDR) lists in Annex XVI several beauty devices that the EU Commission wants to regulate as medical.

The 6-Step Checklist For IVDR Compliance

The 6-Step Checklist For IVDR Compliance By Hilde Viroux and Hans Mische, PA Consulting The in vitro diagnostic devices industry has until May 25, 2022 to bring products, documentation, and quality management systems into compliance with the new EU Regulation on In Vitro Diagnostic Devices 746/2017 (IVDR). This regulation is a major revision, focusing on patient safety, requiring more clinical evidence, improving traceability in the supply chain, and enforcing a proactive post-market surveillance system to ensure early detection of problems. The past year presented a challenge in implementing the IVDR while the COVID-19 pandemic forced the industry to focus efforts on bringing COVID-19 tests to the market. The May 2022 deadline is quickly approaching and there is no sign that the EU Commission is considering postponing it. Even if the deadline is pushed back, the expectation is that it would only be for a year, similar to the extension granted for the medical devices regulation. F