Regulatory Compliance - Operon Strategist

Regulatory Challenges for Blood Collection Tubes under EU IVDR in Germany

Introduction: EU IVDR and Its Impact on Blood Collection Tubes The regulatory environment for blood collection tubes under EU IVDR in Europe has undergone a fundamental transformation with the enforcement of the European Union In Vitro Diagnostic Regulation (EU IVDR 2017/746). Devices that were previously regulated as low-risk products under the In Vitro Diagnostic Directive […]

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EU MDR Compliance Challenges for Medical Device Manufacturers in Germany

Regulatory Compliance / Shubham

Understanding EU MDR Compliance in Germany The European Union Medical Device Regulation (EU MDR) has transformed how medical devices are regulated across Europe. For manufacturers targeting or operating in Germany, achieving EU MDR compliance in Germany is particularly demanding due to strict regulatory oversight, limited Notified Body capacity, and heightened expectations for clinical evidence and

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Disposable Medical Device Manufacturing and Regulatory Approvals in Germany

Overview of Disposable Medical Device Manufacturing Germany is one of the most advanced and quality-focused healthcare markets in Europe. The demand for disposable medical devices is rising significantly due to infection control measures, patient safety protocols, an aging population, and increasing outpatient procedures. These single-use products—including syringes, catheters, IV sets, diagnostic swabs, and surgical gowns—minimize

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BfArM Vigilance Reporting Process for Medical Devices

Regulatory Compliance / Shubham

BfArM Vigilance Reporting Process for Medical Devices Ensuring patient safety and compliance with post-market obligations is a critical requirement for medical device manufacturers in Germany. The Federal Institute for Drugs and Medical Devices (BfArM) plays a central role in overseeing these requirements through its official BfArM Vigilance system. This blog explains how to manage incident

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EU MDR Compliance Checklist for Germany: What Manufacturers Must Know

Regulatory Compliance / Shubham

What Is MDR Compliance? MDR compliance refers to a manufacturer’s ability to meet the legal, technical, and clinical requirements outlined in EU MDR 2017/745 for medical devices intended for the European market. It covers product safety, performance, technical documentation, post-market surveillance, and vigilance systems. In Germany, the Federal Institute for Drugs and Medical Devices (BfArM)

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