EU MDR: Welcome to the New Reality

ARTICLE SUMMARY:

A panel of medtech CEOs and regulatory experts discuss what the future is likely to hold with the impending advent of the new European Medical Device Regulation. The key takeaway: be prepared for a major shift for everyone—large and small companies, new and existing products, European and US manufacturers and investors. There is no escaping the impact of MDR.

Medtech, as an industry broadly speaking, is highly compartmentalized across a range of parameters, among them different clinical or therapeutic categories, companies of varying sizes, global geographic variations, and an assorted range of functional responsibilities within organizations ranging from product companies to investors. As a result, new trends or changes in the rules governing one area may not have much impact on other spaces, siloed as they are. The impending new European Medical Device Regulation (MDR) stands as an exception to that pattern in that these new rules are poised to have a significant effect on a broad swath of the medtech landscape, extending well beyond European borders.

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