Nobel Biocare receives EU Medical Device Regulation Quality Management Certificate
Nobel Biocare is pleased to announce the receipt of the EU Medical Device Regulation (MDR) Quality Management System certification by its Notified Body, the BSI Group, the Netherlands B.V. This signifies that Nobel Biocare’s Quality Management System, and the corresponding first group of products, meet the requirements of the new MDR implemented by the European Union.
“BSI is delighted to have successfully issued our first Dental devices, Class I Reusable and Class IIb Well Established Technology certificates under the new EU Medical Device Regulation (MDR), on behalf of Nobel Biocare, another important step within BSI’s rapidly increasing MDR certification activity.” Gary Slack. Senior Vice President – Global Medical Devices, BSI
Achieving this important milestone establishes Nobel Biocare as one of the first companies to achieve MDR certification in the dental device field.
“Receiving the MDR certificate is an important milestone for Nobel Biocare and shows that we are right on track in our efforts to achieve MDR certification * for our full portfolio,” commented Nobel Biocare Systems president, Patrik Eriksson. “It demonstrates the commitment to our customers and their patients to ensure that our products and solutions remain available as new regulations go into effect. This continues our long-standing commitment of meeting the highest quality and scientific standards for the safety and well-being of patients treated with our products and solutions.”
Implemented by the European Union in 2017, the new Medical Device Regulation was due to become fully active on May 26, 2020, now confirmed to be delayed by a year, with a transition period lasting until May 2024. It will replace the current Medical Device Directive and the EU's Directive on active implantable medical devices.
Nobel Biocare is a world leader in the field of innovative implant-based dental restorations. The company's portfolio offers solutions from single tooth to fully edentulous indications with dental implant systems (including key brands NobelActive® and NobelParallel™ and ceramic implant NobelPearl™*) a comprehensive range of high-precision individualized prosthetics and CAD/CAM systems (NobelProcera®), digital solutions for treatment planning and guided surgery (NobelClinician® and DTX Studio™ suite) as well as biomaterials. Nobel Biocare supports its customers through all phases of professional development, offering world-class training and education along with practice support and patient information materials. The company is headquartered in Zurich, Switzerland. Production takes place at four sites located in the United States, Sweden and Japan. Products and services are available in over 80 countries through subsidiaries and distributors.
*Distributed by Nobel Biocare. Manufactured by Dentalpoint AG