The European Union Medical Device Regulation (EU MDR) governs the production, distribution of medical devices in Europe, and compliance is mandatory for companies who wish to sell medical devices in European markets. These regulations have significant implications across the medical device product lifecycle including product design & development, commercialization and post-market surveillance.
From a business perspective, medical device & technology (or MedTech) companies may face challenges such as resource constraints, a lack of familiarity with the regulation, and the need to update older products to comply with the EU MDR. On the technological front, medical device manufacturers may struggle with disjointed and siloed systems, particularly in light of the EU MDR’s requirement for comprehensive, data-intensive total product lifecycle management.
A platform approach that centralizes all data related to a product’s lifecycle can facilitate traceability, visibility, and continuity, enabling manufacturers to effectively meet the EU MDR’s requirements and beyond.
In this webinar, we will delve into the following topics:
The latest developments and timelines related to EU MDR compliance
Strategies for addressing major challenges faced by the industry, including how AtriCure has addressed EU MDR requirements
The digital transformation necessary to effectively meet EU MDR requirements and beyond