The Notified Body designation has been granted for all technology types
DNV GL, the Oslo-based international accredited registrar and classification society, has achieved designation as a Notified Body by the Norwegian Health Authorities and the European Commission for Medical Devices Regulation (EU) 2017/745 (MDR).
The designation has been granted for all technology types applied for, including the highest risk Class III devices.
“We are excited to have the notification," said Nicola Privato, Global Operations & Technical Services Director, DNV GL – Business Assurance. "With our international network, 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 orthopaedic implants.”
For MDD, DNV GL has been operating under two notified bodies for CE Marking in the medical sector, DNV GL Presafe AS (2460) and Presafe Denmark AS (0543)
In 2017, the company decided to apply for MDR notification in Norway only (Notified Body 2460) to provide a more effective service for our customers by combining our global technical resources under one Notified Body system.
DNV GL said it has over 150 specialists located in over 20 countries allowing the company to provide a truly global service, with local customer support and audit/assessment activities.
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:
The European Commission overhauled in 2015 the former regulatory mechanisms due to diverging interpretation of the older Directives.
Numerous highly publicised incidents highlighted the weaknesses in the legal systems. It damaged patient confidence and consumer trust and that of healthcare professionals in medical device safety and performance.
“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,” Privato commented.
“Notified Bodies are also under significantly increased regulatory oversight, including dramatically increased requirements for clinical competence. Being among the first to achieve this designation reflects the investment and dedication of our colleagues to providing high-quality conformity assessment services for the benefit of patient safety,” he concluded.
In 2020, Notified Body 2460 intends to submit a further application for In-vitro Diagnostic Devices Regulation (EU) 2017/746 (IVDR) to also provide a global service for this rapidly growing sector.