Hearing implant manufacturer MED-EL has received European Medical Device Regulation (MDR) certification. The company becomes one of the world’s first to receive certification in a number of categories, such as medical devices of the highest risk class (Class III), Class III Implantable Custom-Made Devices, and Class I reusable surgical instruments.

In order to gain the certification MED-EL undertook a lengthy process involving establishing an internal cross-functional team. Under senior management’s guidance and regulation, the team was sub-divided to tackle key topics. These specialist teams focused on analysing the implications of MDR compliance for the company’s products. Finally, the company completed a successful MDR audit in 2019.

Originally scheduled to come into force from May 26 this year, MDR has been delayed for a year as a result of the COVID-19 pandemic. The regulation, which will apply to all manufacturers producing and selling medical devices in Europe, seeks to provide greater protection of public health and safety through more stringent product requirements.

Elizabeth Gfoeller, corporate director for regulatory affairs at MED-EL, commented: MDR certification is essential to our business and it took an incredible collective effort to ensure that we are compliant so far in advance of the deadline.”

“We committed to becoming an early MDR adopter back in 2016, in order to maintain our leadership in Europe. With MDR certification in place, we can now continue our mission to put an end to hearing loss and provide patients and practitioners with leading-edge solutions that meet these new stringent standards.”

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