DORNIER MEDTECH is the first urological medtech company in the world to receive MDR certification from the European Union.
Dornier MedTech (Dornier) has become the world’s first urological medtech company to be certified under the European Union’s new Medical Device Regulation (MDR). The certification guarantees clinics the highest device quality for the growing prevalence of kidney stone disease.
Even before the new MDR certification comes into force on 26 May 2021, Dornier MedTech’s devices already meet the new upscale standard, which replaces the previous EU Medical Device Directive (MDD). The new EU MDR certification includes a more robust regulatory framework that enforces a higher standard of public health and patient safety. Despite the challenges imposed by COVID-19, Dornier has achieved EU MDR certification, one of the highest global standards. This is proof that Dornier has the expertise to fulfil its commitment to urology and meet the growing demands of the field.
Dornier has received MDR certification for its Class IIb products: Dornier Delta® III, one of the most powerful lithotripters on the market, which uses Dornier’s extracorporeal shock wave lithotripsy (ESWL); and Dornier UIMS™, a state-of-the-art information management software that helps clinicians treat kidney stones through improved imaging and efficiency.
Yau Chung Wong, Chief Operating Officer at Dornier MedTech, commented:
“This certification is an important milestone for us. It is a testament to the high quality of Dornier’s ESWL medical devices, which is now the gold standard for non-invasive kidney stone treatment, which will greatly strengthen the ability of clinics to continue to provide the highest standard of care to patients.”
Dornier pioneered ESWL, the first non-invasive treatment for kidney stones, and is committed to expanding its presence in urology by expanding its portfolio, which now includes urological lasers, ESWT solutions and urological consumables. True to its spirit of innovation, Dornier consistently delivers advanced urological solutions based on the latest technologies that enable urologists to provide optimal care to their patients.
Dornier is headquartered in Weßling near Munich and is a subsidiary of Advanced MedTech, a leading medical technology company based in Singapore.