The proposal should be ready in early April, it then needs approval from the European Parlement and heads of state in the European Council. If it gets approved, the deadline should be moved to May 2021.Many people are worried about the new regulation, Jeffrey B Jump (chairman and CEO of MedAlliance) wrote in an article last October (2019) that “MDR could become the most disruptive factor to hit the European healthcare market since the start of the Second World War”. He thinks that more than 500,000 products affected by the MDR will not get reapproved by the EU because of the time and investment needed to translate all of the content in 24 languages. He adds that some companies will have to translate up to 80,000 devices which is a big challenge. He adds “Obtaining a CE mark was simple for companies to understand and relatively easy to achieve. But the majority of companies, as well as notified bodies, neither fully understand how to interpret MDR nor foresee the difficulties of getting it implemented”. All of this has made some industry experts think that the EU will loose up to 30% of its medical companies operating on the continent. With all those challenges coming up and the ongoing crisis, it is safe to assume that the deadline will be pushed to next year. This gives us all more time to get ready for this change. Questions that you may ask yourself:
- Are your devices subject to re-classification?
- Will UDI compliance force the re-labeling of existing devices?
- How should you get ready for the MDR? Language services providers, like Powerling, understand the new requirements, will be able to proactively support you in achieving timely compliance with the new regulation. We have a solid background in medical device translations and can help you address the challenges of the IFUs and the new UDI labeling requirements.
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