The E.U.’s Medical Device Regulation (MDR) takes effect tomorrow, changing the process to gain entry to the continental market.
EU MDR replaces the EU Medical Device Directive (MDD) with more stringent requirements on the companies that perform the audits for each device, also known as notified bodies. The change affects not only devices that are new to the EU market but those that entered the market under MDD and must be re-certified under MDR to remain available for sale — a costly and time-consuming process.
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