Recognition of DNV as an authorised entity for IVDR certification confirmed
In a significant development for the medical device industry, DNV, a leading global assurance provider, has been recognized by the European Commission as a notified body for the certification of devices under the European Union's In Vitro Diagnostic Regulation (IVDR).
Stricter Regulatory Framework and Risk Classification
The IVDR introduces a more stringent regulatory framework, distinguishing in vitro diagnostic devices into four risk classes (A, B, C, D) based on the potential harm to patients and public health. Higher-risk devices (Classes B, C, and D) require more rigorous conformity assessment and notified body involvement, including audits and technical documentation assessments.
Notified Body Involvement
For all but the lowest risk devices, conformity assessment by a designated Notified Body is mandatory. This includes quality management system (QMS) audits, thorough review of technical documentation, testing, and in some cases additional consultations with authorities or European Reference Laboratory verification, especially for Class D devices. Companion Diagnostics (CDx) also require consultation with competent authorities or the European Medicines Agency.
Clinical Evidence and Performance Evaluation
Manufacturers must provide robust clinical evidence and performance evaluation reports, supporting the safety and efficacy claims of their devices under IVDR standards. For some Class D devices, expert involvement and third-party verification of performance claims are required.
Extended Transition Deadlines and Legacy Devices
The IVDR came fully into force on May 26, 2022, but transition deadlines for devices certified under the older IVDD have been extended due to notified body capacity constraints. The deadlines are phased by device risk class:
- Class D devices: May 26, 2025
- Class C devices: May 26, 2026
- Class B and sterile Class A devices: May 26, 2027
Extensions require no significant changes to device design/purpose post-May 2022 and continued compliance with IVDR post-market surveillance, vigilance, and registration requirements.
EUDAMED Registration and UDI Requirements
All economic operators (manufacturers, authorized representatives, importers) must register in the EU database EUDAMED with detailed data on devices, including Unique Device Identification (UDI) information as per Articles 26 and 28 of IVDR. Labeling, Instructions for Use (IFU), and traceability demand meeting detailed Annex requirements, including language rules, UDI carriers, CE marking, and storage/warning information.
Enhanced Post-market Surveillance (PMS) and Vigilance
The IVDR demands a proactive and continuous post-market surveillance system aligned with higher safety standards. PMS data informs ongoing device evaluation and risk management.
DNV, with its extensive expertise and technical competence in the field of IVD device certification, aims to reduce risks and help manufacturers get to market faster through its IVD device certification process. The company offers a fully digital process for faster, more transparent device certification, allowing manufacturers to manage certification documents online and track compliance status in real time via a secure digital platform.
MRC Holland, a company in the medical device manufacturing industry, has already received IVDR certification for its newborn screen assay. DNV is ready to collaborate with manufacturers of all classes of IVD devices to facilitate their entry into the EU market. The designation of DNV as an IVDR notified body brings greater capacity to the certification market, helping more device manufacturers access the EU market.
The safety and effectiveness of in vitro diagnostics (IVDs) are crucial to public and personal health. The European In Vitro Diagnostic Regulation (IVDR) is a topic of ongoing discussion in the medical device manufacturing sector. The main regulatory changes in 2024 for medical devices and IVDs are a significant focus of interest.
Sources:
- RegDesk overview on IVDR compliance and timelines (2025)
- SimplerQMS on CE marking and notified body requirements under IVDR (2025)
- Team NB consensus on IVDR certification process (2025)
- Proregulations summary of IVDR requirements and changes from IVDD (2025)
Medical-devices, such as in-vitro diagnostic (IVD) devices, play a vital role in public and personal health, with the European In Vitro Diagnostic Regulation (IVDR) playing a crucial part in ensuring their safety and effectiveness. DNV, a recognized notified body for device certification under the IVDR, uses its technical expertise to help medical-device manufacturers navigate the stricter regulatory framework and risk classification, ensuring compliance with health-and-wellness standards set by science. Manufacturers are required to provide robust clinical evidence and performance evaluation reports to support the safety and efficacy claims of their devices under IVDR standards, and some higher-risk devices may require expert involvement and third-party verification to meet the stringent requirements set by IVDR.
