Ultimate Guide EU MDR GSPR

Read: Your Guide to the EU MDR General Safety and Performance Requirements (GSPR)

With the European Medical Device Regulation (MDR) looming, medical device companies are focusing on ensuring compliance with the new regulations. One of those key aspects of compliance is to ensure your devices conform to the General Safety and Performance Requirements (GSPR). Read this free guide for practical guidance on how to meet those requirements.

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Competent Authority, Notified Body, Authorized Representative – who’s who and what do they do?

Marketing medical devices in the European Economic Area (EEA) can be a challenge. Some regulatory activities require interactions with regional level authorities, while others are handled by Member States. This article explains the different regulatory bodies that oversee medtech products within the European region.

Quick Reference Guide: Global Medical Device UDI Requirements and Timelines

Keeping track of country-specific UDI requirements, implementation timelines, and affected devices can be a big challenge to RA teams—especially because information is scattered across many sources. This guide consolidates timeline information and device class requirements across multiple regions.

The Ultimate Guide to the China NMPA UDI System and Database

eBook excerpt - In 2019, Chinese medical device regulations added a provision that devices carry a unique device identification (UDI). China's UDI requirements are similar to those in the US and EU. They establish specific device ID and labeling requirements, as well as a central, state-administered device database.

The Ultimate Guide to the EU MDR/IVDR UDI

eBook excerpt - The EU Medical Device Regulation (2017/745) (“MDR”) and EU In Vitro Diagnosis Regulation (2017/746) (“IVDR”) introduce two new systems for information exchange: (1) UDI (Unique Device Identifier) for device identification and (2) EUDAMED (European Databank on Medical Devices) to centralize and disseminate information.

Dispatches from RAPS Convergence: The State of Regulatory Tools

A few weeks ago we attended RAPS Euro Convergence. The event brought together regulatory professionals from across the European region for several days of immersive learning. At Rimsys, we took advantage of the opportunity to explore the state of regulatory tools and processes in the region, and see how they compare to North American teams.

Building a business case for a RIM system

Regulatory information management (RIM) systems are still relatively new to a lot of MedTech companies. RIM systems help companies digitize and automate regulatory activities associated with their products. The value of an automated solution is pretty obvious, but quantifying that value can be harder.