Global Pharmacovigilance Requirements for Devices and Combination Products

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Global Pharmacovigilance Requirements for Devices and Combination Products

With the increasing complexity of healthcare products, pharmacovigilance requirements are evolving to include not only drugs but also medical devices and combination products. Globally, regulatory authorities are placing greater emphasis on post-market surveillance to ensure patient safety and product efficacy across all categories.

Global Pharmacovigilance Requirements

For medical devices, regions such as the EU have implemented comprehensive regulations under the MDR (Medical Device Regulation), mandating continuous safety monitoring, incident reporting, and periodic safety update reports (PSURs). Similarly, the U.S. FDA requires manufacturers to report adverse events through the Medical Device Reporting (MDR) system and encourages active surveillance.

Combination products—which integrate drugs, devices, or biologics—face more complex regulatory pathways. These products must comply with pharmacovigilance standards applicable to each component, along with additional guidance specific to the product type. For instance, in the U.S., the FDA requires combination product manufacturers to follow a streamlined yet integrated system for safety reporting.

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