December 17, 2018

By Karen Davison

Mike Graney (CRDA’s VP of Global Business Development) and I recently returned from a two-week marketing mission to Europe, where we raised awareness of Charleston’s business opportunities. The first week landed us in Düsseldorf, Germany to attend Medica, the world’s largest medical device tradeshow. The second leg of the trip included seven cities in the Netherlands, with companies from aerospace, automotive, IT, and paper/packaging industries. Here are our top takeaways:

FDA & EU MDR = BFF

In almost every conversation at Medica, the question “Do you have FDA approval?” was raised and the answer was almost always “not yet” or “getting close.” Obtaining U.S. Food & Drug Administration (“FDA”) approval is often a cumbersome and rigorous process for medical device makers that can stretch over years. As a result, foreign companies are understandably reluctant to open a U.S. location until the FDA clears their products.

FDA, meet EU MDR. By 2020 all medical devices sold in the EU must be fully-compliant with the new European Medical Device Regulation (“EU MDR”). Significant updates to medical device regulation in the EU have not been made since the early 1990s – that’s almost 30 years! The good news is EU MDR is more consistent with U.S. FDA approval of medical devices. Now that the U.S. and EU have similar rules governing the life sciences industry, we could see an uptick in life sciences foreign investment over the next several years. Stay tuned!

EMA says Thank u, Next to London

Brexit is leading to another shake-up for the life sciences industry in Europe. The European Medicines Agency (“EMA”), the EU equivalent of the FDA, confirmed its move from London to Amsterdam. This transition will begin mid-2019 and is expected to finish by 2020. The EMA’s move to Amsterdam will support the Dutch life sciences hub. In addition to the EMA, the Netherlands is also home to one of the world’s fastest-growing airports, Europe’s largest seaport, and the highest number of patent requests in the world. The Netherlands has strong momentum and will continue to be a hotbed for projects for the Charleston Region.

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