Jacoti, a specialist in advanced hearing technologies, has received EU Medical Device Regulation (MDR) certification for its Class IIa devices – Jacoti Hearing Center and Jacoti Hearing Center Pro.
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MDR checklist
Jacoti's attainment of the MDR certification is an important milestone in the company’s aim to help revolutionise hearing technologies. This certification positions Jacoti as being able to provide solutions for those companies wishing to build hearing aid products on cost-effective consumer technology platforms.
To ensure a smooth transition for Jacoti's devices – previously CE marked under the MDD – a comprehensive strategy had been developed to obtain conformance with the MDR requirements.
The European Union (EU) introduced the MDR to modernise and strengthen the EU legislative framework governing medical devices. However, the transition from the previous Medical Device Directive (MDD) to MDR has presented a significant challenge for many manufacturers.
