DNV granted status as an authorized body for IVDR certification
The European Union's regulatory landscape for In Vitro Diagnostic (IVD) devices is undergoing a significant transformation, with the In Vitro Diagnostic Regulation (IVDR) 2017/746 set to take effect in full by 2024. This new regulation represents a substantial tightening and enhancement of regulatory oversight compared to the earlier IVDD framework, focusing on patient safety, device performance, and post-market control.
DNV, a global assurance and risk management company, offers extensive expertise and technical competence in IVD device certification. Recognized by the European Commission as a notified body for certifying devices under the EU's In Vitro Diagnostic Regulation (IVDR), DNV is well-positioned to assist manufacturers in navigating these regulatory changes.
Under the new IVDR, devices previously certified under the IVDD have extended transition deadlines until as late as 2027-2029 if manufacturers meet certain conditions and actively progress toward IVDR compliance. Devices formerly self-declared or certified under IVDD now generally require conformity assessment by a Notified Body, a major increase from the previous 10% under IVDD. Manufacturers of some IVDD certified or Class D self-declared devices must enter written agreements with Notified Bodies.
The IVDR imposes a substantially more rigorous and clearly defined requirement for clinical evidence. This includes continuous performance evaluation involving scientific validity, analytical performance, and clinical performance. Manufacturers must document performance evaluation thoroughly with well-analyzed data to demonstrate safety and effectiveness according to the intended purpose, addressing the expanded criteria for intended use and safety.
Post-market surveillance and reporting are also subject to stricter requirements. Manufacturers must actively monitor their devices after market entry through proactive post-market surveillance and submit periodic safety update reports (PSUR). Reporting of incidents, including non-serious ones, must now be made via a centralized EU portal with accelerated timelines.
The IVDR requires updated technical documentation, including labeling, clinical data, and risk management processes. Manufacturers must maintain compliance with standards such as ISO 13485 for quality management systems.
Unique Device Identification (UDI) requirements also align with IVDR principles, enabling better traceability of IVD devices across the supply chain. Certain device types, such as standalone software or substance-based devices, may face new classification rules and reclassification into higher-risk categories under EU regulations, impacting conformity assessment routes.
DNV's digital certification process allows manufacturers to manage certification documents online and track compliance status in real time via a secure digital platform. This forward-thinking approach to certification facilitates faster, more transparent device certification for manufacturers. The designation of DNV as an IVDR notified body brings greater capacity to the certification market, helping more device manufacturers access the EU market.
Cecilie Gudesen Torp, Global Director of Medical Services, Supply Chain & Product Assurance at DNV, expressed this forward-looking sentiment, "We are anticipating collaboration with manufacturers of all classes of IVD devices to facilitate their entry into the EU market. Our goal is to reduce risks and help manufacturers expedite their market entry."
Recently, MRC Holland's newborn screen assay has received IVDR certification, demonstrating the effectiveness of DNV's certification process. As significant regulatory changes for Medical Devices and IVD's are expected in 2024, DNV's global team of auditors, technical assessors, and clinicians are poised to deliver efficient certification with uncompromising reliability.
In vitro diagnostics (IVDs) are tests used to determine a person's health status, ranging from pregnancy and cholesterol tests to HIV screening, COVID-19 tests, and cancer marker detection. The EU introduced the IVDR in 2017, replacing its previous In Vitro Diagnostic Directive 98/79/EC (IVDD). As manufacturers prepare for these regulatory changes, DNV stands ready to support them in ensuring timely compliance, extensive clinical evidence, and quality assurance to market IVD devices legally in the EU beyond 2024.
- As the In Vitro Diagnostic Regulation (IVDR) 2017/746 takes effect, DNV, a global assurance and risk management company, is well-positioned to assist medical device manufacturers in navigating these regulatory changes related to health-and-wellness offerings, specifically In Vitro Diagnostic (IVD) devices.
- Under the new IVDR, manufacturers must demonstrate safety and effectiveness of their IVD devices according to the intended purpose, addressing the expanded criteria for intended use and safety, which requires substantial clinical evidence, including continuous performance evaluation, well-analyzed data, and compliance with standards such as ISO 13485 for quality management systems in the context of science and medical-conditions.
