DNV GL has successfully achieved designation as a Notified Body in Oslo by the Norwegian Health Authorities and the European Commission for Medical Devices Regulation (EU) 2017/745 (MDR.)
The designation was successfully granted for all technology types applied for, including the highest risk Class III devices. DNV GL is among the first to receive the notification.
Nicola Privato, Global Operations & Technical Services Director, DNV GL – Business Assurance said: “We are excited to have the notification. With our international network, which is under expansion to service customers with medical device certification globally, we are ready to continue to provide quality service to support companies in gaining European market access for medical devices, such as coronary and vascular stents and orthopedic implants.”
After operating under two notified bodies for CE Marking in the medical sector, DNV GL Presafe AS (2460) and Presafe Denmark AS (0543.) The MDR notification is in Norway only (Notified Body 2460) to provide a more effective service for customers by combining our global technical resources under one Notified Body system. With over 150 specialists located in over 20 countries, this allows DNV GL to provide a truly global service, with local customer support and audit/assessment activities.
Improving patient safety
Medical Devices Regulation (EU) 2017/745 will replace the current Medical Device Directive (MDD) and the Active Implantable Medical Device Directive (AIMD), whereas the IVDR will replace the In vitro Diagnostic Directive (IVDD). Both regulations bring a series of important improvements to conformity assessment for medical devices with the intention to:
- Improve the quality, safety and reliability of medical devices placed on the European market.
- Strengthen transparency of information related to medical devices for consumers and practitioners.
- Enhance vigilance and market surveillance of devices in use.
“The new regulations apply a far higher degree of regulatory scrutiny on device safety and performance characteristics, clinical evaluation, risk/benefit demonstration and transparency of post-market device performance,” said Nicola Privato.