Nobel Biocare ontvangt EU MDR Kwaliteitssysteem Certificatie

20 april 2020 - Nobel Biocare heeft bekend gemaakt dat het de certificatie van het kwaliteitsmanagementsysteem  van de EU Medical Device Regulation (MDR 2017/745) heeft ontvangen. Ingangsdatum hiervan is 26 mei 2020, mogelijk wordt deze datum met 1 jaar uitgesteld. Het hierna volgende bericht is bekend gemaakt. 

 

Zurich, 20.04.2020

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 certification¹ 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 most likely 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.

 (1)  Pending final audit of the technical files

 

 

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