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.
MED-EL Medical Electronics, a leader in implantable hearing solutions, is driven by a mission to overcome hearing loss as a barrier to communication. The Austrian-based, privately owned business was co-founded by industry pioneers Ingeborg and Erwin Hochmair, whose ground-breaking research led to the development of the world’s first micro-electronic multi-channel cochlear implant (CI), which was successfully implanted in 1977 and was the basis for what is known as the modern CI today. This laid the foundation for the successful growth of the company in 1990, when they hired their first employees. To date, MED-EL has grown to more than 2,200 employees from around 75 nations and has 30 locations worldwide.
The company offers the widest range of implantable and non-implantable solutions to treat all types of hearing loss, enabling people in 124 countries enjoy the gift of hearing with the help of a MED-EL device. MED-EL’s hearing solutions include cochlear and middle ear implant systems, a combined Electric Acoustic Stimulation hearing implant system, auditory brainstem implants as well as surgical and non-surgical bone conduction devices. www.medel.com
Doz. DI Dr DDr med. h.c. Ingeborg Hochmair
MED-EL Medical Electronics
T: +43 5 7788-0