"DNV receives designation as an authoritative body for IVDR certification"

In the realm of healthcare, in vitro diagnostics (IVDs) play a crucial role in determining a person's health status, from pregnancy tests to HIV screening, COVID-19 tests, and cancer marker detection. As the European Union (EU) continues to prioritise the safety and effectiveness of these tests, the In Vitro Diagnostic Regulation (IVDR) has been introduced to provide a regulatory basis for new IVD devices.

The IVDR, which came into effect in May 2022, marks a significant shift from the previous In Vitro Diagnostic Directive 98/79/EC (IVDD). Key regulatory advancements under the IVDR include a new risk-based classification system, expanded requirements for clinical evidence, technical documentation, and post-market surveillance, and mandatory Notified Body involvement for approximately 80–90% of devices that were previously self-certified under the IVDD.

The IVDR classifies IVD devices into four risk classes with differing certification requirements:

Class A: Lowest risk (e.g., laboratory instruments, specimen receptacles) - Non-sterile Class A devices can be self-certified; sterile Class A devices require Notified Body certification.
Class B: Moderate risk (e.g., some immunoassays, fertility tests) - Require Notified Body certification.
Class C: Higher risk (e.g., infectious disease tests, companion diagnostics) - Require Notified Body certification by May 26, 2026.
Class D: Highest risk (e.g., blood screening, tests for life-threatening diseases, blood compatibility) - Must have Notified Body certification by May 26, 2025.

Cecilie Gudesen Torp, the Global Director of Medical Services, Supply Chain & Product Assurance at DNV, has expressed eagerness to assist manufacturers of all classes of IVD devices in accessing the EU market. DNV, recognised by the European Commission as a notified body for the certification of devices under the IVDR, offers a fully digital process for faster, more transparent device certification.

Manufacturers must meet heightened demands for clinical performance data and implement robust quality management systems supporting ongoing performance monitoring and lifecycle management. DNV, with its extensive expertise and technical competence in IVD device certification, aims to deliver efficient certification with uncompromising reliability to reduce risks and help manufacturers enter the market faster.

The designation of DNV as an IVDR notified body brings greater capacity to the certification market, helping more device manufacturers access the EU market. As one of the top 5 notified bodies for medical device certification, DNV is well-positioned to support manufacturers in navigating the IVDR's regulatory landscape and ensuring compliance with the new requirements.

The safety and effectiveness of IVD devices are crucial to public and personal health. With the IVDR's emphasis on risk-based classification, extensive clinical evidence, post-market surveillance, and expanded Notified Body involvement, manufacturers can be confident that they are meeting the highest standards for the protection of public health.

References:

[1] European Commission. (2021). IVDR – In-vitro diagnostic medical devices. Retrieved from https://ec.europa.eu/health/medical_devices/viv/index_en.htm [2] European Commission. (2021). IVDR – Classification, performance studies and conformity assessment. Retrieved from https://ec.europa.eu/health/medical_devices/viv/classification_en.htm [3] European Commission. (2021). IVDR – Clinical evidence and post-market surveillance. Retrieved from https://ec.europa.eu/health/medical_devices/viv/clinical_evidence_en.htm [4] European Commission. (2021). IVDR – Notified bodies. Retrieved from https://ec.europa.eu/health/medical_devices/viv/notified_bodies_en.htm [5] European Commission. (2021). IVDR – Transition period and timeline. Retrieved from https://ec.europa.eu/health/medical_devices/viv/transition_en.htm

The IVDR, being a regulatory framework for in vitro diagnostic devices, underscores the importance of science in the development of medical devices to address various medical-conditions for health-and-wellness purposes, such as infectious disease tests and blood compatibility assays. To meet the increased regulatory standards established by the IVDR, manufacturers need to comply with heightened demands for clinical performance data and implement robust quality management systems, collaborating with Notified Bodies like DNV, which will help them navigate the EU market more efficiently and ensure their products maintain the highest safety and effectiveness standards for public health.