Jan 2024 – A wonderful piece of news to kick-start the new year. A couple of years back, the EU Parliament legislated the transitional provisions from Medical Devices Directive (MDD) to Medical Devices Regulation (MDR). The new standard took into consideration the need for more stringent technical documentation, implementation of unique device identification (UDI) for better traceability and recall and added rigorous post-market surveillance.
We were just informed by TÜV SÜD, our notified body designated to assess the conformity of SELENA+ that we have cleared the MDR audit. This is well ahead of the 31 December 2028 dateline set by the EU.
This achievement ensures EyRIS enjoys continued access to the EU market and countries that recognises this certification within their jurisdiction.
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