Norway’s DNV GL Designated as 10th Notified Body Under MDR
Norwegian notified body (NB) DNV GL Presafe AS on Thursday was added to the European Commission’s NANDO database as the 10th NB to be designated under Regulation (EU) 2017/745 on medical devices (MDR).The designation covers certain active non-implantable devices, non-active implants and non-active, non-implantable devices. “The designation was successfully granted for all technology types applied for, including the highest risk Class III devices, ensuring continuity of European market access for our customers’ life-saving medical technology,” the company said.
DNV GL also said on its website that its local sales offices will contact existing Medical Device Directive (MDD) customers directly to plan for an orderly migration to MDR based on their individual circumstances and readiness.
The company said it recognizes that NB capacity “is limited and so will prioritize MDR Applications in the following order:
- Existing customers with MDD certificates expiring, based on expiry date.
- Existing customers with MDD certificates subject to significant change.
- New customers.”
NBs designated under MDD may continue to issue certificates against these requirements up to and including 25 May (MDR applies 26 May). These MDD certificates will be valid until their original expiry date, or 26th May 2024, whichever is sooner, the company added.
DNV GL joins four German NBs, three Dutch NBs, one from the UK and one from Italy. DNV GL also plans to apply for designation under Regulation (EU) 2017/746 (IVDR). Just three NBs have been designated under IVDR so far.
Concerns about NB capacity have lingered since the designation process began, but the European Commission maintains that the hope is to achieve 20 MDR and IVDR designations by the end of the first quarter of 2020. The commission also said 44 NBs have applied for designation under MDR.
NANDO