ARTICLE SUMMARY:
Switzerland has taken the first step toward an historic solution to the problems with MDR by potentially aligning with the FDA and breaking away from the rest of Europe. But a bigger issue remains for the EU that has gone relatively unnoticed: thousands of legacy devices with expiring MDD certifications might have to be pulled from the market because they won’t receive MDR certification by the 2024 deadline due to the bottleneck in the system. No solution is in sight.
If desperate measures are the metric for determining desperate times, then that appears to be where things stand with the EU’s Medical Device Regulation (MDR), both in terms of measures actually taken and those being contemplated. Nowhere is that more clearly apparent than in the recent action in the Swiss Parliament on November 28 when it took the first step toward having Switzerland break with the rest of Europe by adopting a measure that would employ FDA standards, rather than those imposed by MDR, in order for medical devices to gain access to the Swiss market. And that is far from the biggest issue facing the EU under MDR.
