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MED-EL Elektromedizinische Geräte GmbH

Austria-based MED-EL is a leading provider of hearing implant systems with 32 subsidiaries worldwide.

Lobbying Activity

Meeting with Nora Bednarski (Cabinet of Commissioner Helena Dalli)

23 Nov 2023 · The impacts of assistive technologies for persons with hearing loss including employment and social inclusion, as well as upcoming disability rights and health union priorities.

Response to Electronic instructions for use for medical devices

25 May 2021

We acknowledge the proposed update to Regulation 207/2012 relating to electronic instructions for use for medical devices, and recognize the value in the provision of such information in electronic form for medical professionals and users of MED-EL hearing implants / devices. In preparation for this we request that the following be considered: 1. We propose that Article 6 (3) (b) is removed from the regulation as the inclusion of Basic UDI-DI and UDI-DI within a resource to facilitate access the electronic Instructions For Use (IFU) does not deliver this purpose. We support the need for effective and easy device identification. For this purpose, the UDI-DI is, and shall remain, visible and available as a label on the product packaging. The devices additionally carry unique identifiers enabling professionals and users to identify the device serial number, manufacturer name and model without the need to access additional labelling. As the purpose of the Basis UDI-DI is not to identify the device at an individual’s point of use, the inclusion of such an extensive list of data on a paper-form leaflet/flyer that seeks to promote access e-IFU adds no value to end users and may cause confusion. Basic UDI-DI is also not a requirement within the IFU itself. In addition, MDR 2017/745 does not require the inclusion of Basic UDI-DI within any labelling material. MED-EL were early adopters of MDR 2017/745 resulting in the company being one of the first manufacturers worldwide, and the first hearing implant manufacturer, to be granted MDR certification. 2. We also note the Annex as referenced in Article 10 was missing from the initial consultation document therefore we were unable to provide comment on these
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