WEVELGEM, BELGIUM — Jacoti BV announced that it has received EU Medical Device Regulation (MDR) certification for its Class IIa devices, the Jacoti Hearing Center and Jacoti Hearing Center Pro.
This certification demonstrates the company’s commitment to excellence in the quality of its software products and internal processes. It also uniquely positions Jacoti to offer cost-effective consumer technology platforms for building hearing aid products and providing quality software for headsets and hearables.1
Jacoti’s attainment of the MDR certification is an important milestone in the company’s mission to revolutionize hearing technologies. To ensure a smooth and timely 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 modernize 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.2 Despite these challenges, Jacoti has been successful in obtaining MDR certification3 highlighting the company’s dedication to delivering high-quality products.
Jacoti remains “well-positioned to continue its innovation in science-based hearing solutions that meet the needs of consumers and comply with regulatory requirements inside and outside the EU market”. With Jacoti Hearing Center leading the way as the first product with MDR certification, Jacoti continues to demonstrate its expertise and leadership in the hearing technology industry.
References:
- Jacoti’s processes and products will continue to be audited on a yearly basis to the MDR requirements as well as to Medical Device Quality Management Standard ISO 13485:2016.
- Notified Bodies have reported that a majority of manufacturers are late with their submissions or showing an overall lack of preparedness (Notified Body position paper on MDR/IVDR Implementation. The European Association for Medical devices of Notified Bodies)
- MDR certificates have not been achieved yet for over 85% of the devices previously certified under the MDD (as of April 2022, MedTech Europe trade association report)
Source: Jacoti BV
