Nobel Biocare receives EU medical device regulation quality management system certification

Nobel Biocare’s quality management system and the corresponding first group of products have met the criteria of the new EU MDR, which was to have become effective by 26 May 2020. (Image: Nobel Biocare)
TextNobel Biocare

ZURICH, Switzerland: Nobel Biocare is pleased to announce the receipt of EU medical device regulation (MDR) quality management system certification by its notified body, the BSI Group The Netherlands.

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 EU.

“BSI is delighted to have successfully issued our first dental devices, Class I reusable and Class IIb implantable—well-established technologies, certificates under the new EU medical device regulation, on behalf of Nobel Biocare, another important step within BSI’s rapidly increasing MDR certification activity,” said Gary Slack, senior vice president of global medical devices at BSI. Nobel Biocare is one of the first to achieve MDR certification for dental devices.

“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 Patrik Eriksson, president of Nobel Biocare Systems. “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 EU in 2017, the new MDR was due to apply from 26 May 2020, but owing to the COVID-19 pandemic, the date has been delayed by one year. The MDR replaces the current medical device directive and the EU’s directive on active implantable medical devices.

* Pending final audit of the technical files.