Regulatory Compliance

Disposable Medical Device Manufacturing and Regulatory Approvals in Germany

Regulatory Compliance, Medical device Manufacturing /

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

BfArM Vigilance Reporting Process for Medical Devices

Regulatory Compliance /

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

EU MDR Compliance Checklist for Germany: What Manufacturers Must Know

Regulatory Compliance /

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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