DNV granted status as authorizing body for IVDR certification
The European Commission has recognised DNV as a notified body for the certification of devices under the European Union's In Vitro Diagnostic Regulation (IVDR). This designation brings greater capacity to the certification market, helping more device manufacturers access the EU market.
In vitro diagnostic (IVD) devices, which include 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, are subject to more rigorous and structured regulatory requirements under the IVDR. The regulation, which replaced the previous IVD Directive (IVDD) in 2017, aims to ensure higher standards of safety and performance for IVD devices in the European market.
Key elements of the IVDR include a new risk-based classification system, stricter notified body involvement, enhanced clinical evidence and performance evaluation demands, stringent post-market surveillance, and traceability and transparency requirements. Manufacturers must proactively plan certification strategies to address notified body capacity constraints, submit complete documentation, and align with timelines to maintain market access in the EU.
DNV, among the top 5 notified bodies for medical device certification, offers extensive expertise and technical competence in IVD device certification. The company's goal is to reduce risks and help manufacturers get to market faster. DNV's global team of auditors, technical assessors, and clinicians are prepared to deliver efficient certification with uncompromising reliability.
Cecilie Gudesen Torp, Global Director of Medical Services, Supply Chain & Product Assurance at DNV, expressed that there will be significant regulatory changes for Medical Devices and IVD's in 2024. Insights suggest that these changes will require manufacturers to reevaluate their strategies and seek out reliable partners like DNV to navigate the complex regulatory landscape.
Recently, MRC Holland, a company in the news for obtaining IVDR certification for its newborn screen assay, has collaborated with DNV to facilitate access to the EU market. DNV is ready to collaborate with manufacturers of all classes of IVD devices to help them achieve compliance with the IVDR and gain access to the EU market.
References:
[1] European Commission. (2020). In vitro diagnostic medical devices: Regulation (EU) 2017/746. Retrieved from https://ec.europa.eu/health/ivdd/index_en.htm
[2] European Commission. (2020). IVDR: Transition and compliance timelines. Retrieved from https://ec.europa.eu/growth/tools-databases/newsroom-and-events/news/ivdr-transition-and-compliance-timelines_en
[3] European Commission. (2020). IVDR: Guidance for manufacturers. Retrieved from https://ec.europa.eu/growth/tools-databases/newsroom-and-events/news/ivdr-guidance-manufacturers_en
[4] European Commission. (2020). IVDR: Notified bodies. Retrieved from https://ec.europa.eu/growth/tools-databases/newsroom-and-events/news/ivdr-notified-bodies_en
[5] European Commission. (2020). IVDR: Impact on the medical device industry. Retrieved from https://ec.europa.eu/growth/tools-databases/newsroom-and-events/news/ivdr-impact-medical-device-industry_en
Science's advancements in medical-conditions diagnostic capabilities have led to an increased need for medical devices that adhere to stringent health-and-wellness standards. With the European Commission recognizing DNV as a notified body for the certification of devices under the EU's IVD Regulation, medical device manufacturers now have a viable partner to ensure their products meet the demanding IVDR performance and safety requirements.
