MED-EL is the first hearing implant manufacturer to receive new European MDR Certification

March 25, 2020 — (Innsbruck, Austria) — MED-EL, the Austria-based global leader in cochlear and hearing implants technology, has become one of the first manufacturers worldwide, and the first and only hearing implant manufacturer in the world, to be granted European Medical Device Regulation (MDR) certification.

Following successful conformity assessment to the new MDR, including an audit of the Quality Management System, MED-EL is also one of the world’s first manufacturers to receive certification for a number of product categories, including medical devices of the highest risk class (Class III), Class III Implantable Custom-Made Devices, and Class I reusable surgical instruments. 

Under the MDR all devices fall into four basic categories (invasive, non-invasive, active and special rules) and are then further segmented into classes. Class III devices (the MDR includes active implantable medical devices) are the highest risk category.

The EU MDR is scheduled to come into effect in EU Member States from 26th May 2020 and will apply to all manufacturers selling medical devices within Europe.  It aims to provide greater protection of public health and safety by setting out far more stringent requirements and obligations. Although there are widespread concerns that failure to meet the deadline for compliance might impact the availability and safety of medical devices in the European Union, MED-EL’s certification is positive news for ENT professionals and patients. 

As part of its strategy, MED-EL committed to becoming an early MDR adopter back in 2016 and has been working for more than three years to develop a plan to transition its devices and quality management system in to MDR’s new legal framework.

MED-EL has always been committed to providing safe and effective devices to the highest standards. With the MDR certification now in place, MED-EL is best placed to make effective use of the so-called MDR “grace period” to transition all its current devices to MDR before 2024, and to ensure continued uninterrupted access to its life-changing technologies.

MED-EL’s Corporate Director for Regulatory Affairs, Elizabeth Gfoeller 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 26th May 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.” 

Click here for more information about MDR regulation.

About MED-EL

CEO 

Doz. DI Dr DDr med. h.c. Ingeborg Hochmair

Press contact

Patrick D`Haese 
MED-EL Medical Electronics 
Fürstenweg 77a 
6020 Innsbruck 
Austria 

T: +43 5 7788-0 
E:  press@medel.com 
www.medel.com