OPAL & Omron: Your Strong Partners for Compliance with MDR and FMD EU Regulations

MDR, IVDR and FMD set new standards for safety and traceability in medical technology and pharma. What the EU regulations mean for your business – and how OPAL and Omron support you in achieving compliance.

MDR – Medical Devices

EU 2017/745: safety, efficacy and traceability of medical devices, with improved clinical evaluation and transparency.

IVDR – In-vitro Diagnostics

EU 2017/746: high safety and accuracy standards for in-vitro diagnostics such as blood and genetic tests.

FMD – Medicinal Products

2011/62/EU: protects the legal pharmaceutical supply chain (EEA) against falsified medicines – relevant for the entire life-science industry.

What this means for you

Compliance is mandatory – and a competitive advantage

These regulations are crucial for manufacturers, distributors and healthcare institutions: they ensure compliance and guarantee patient safety. Those who implement labelling, verification and traceability properly not only meet the regulations – they also build trust along the entire supply chain.

Omron’s verifier solutions check code quality and labelling directly in the line – OPAL integrates them seamlessly into your processes and systems.

The Webinar

Learn from practice: the Medmix journey

Are you ready for the EU regulations? In this exclusive webinar, you will learn how Medmix Switzerland AG mastered the challenges of the EU regulations – and which verifier solutions from Omron & OPAL supported them along the way.