#Medical Devices #Norway #Oslo #DNV #IVDR

DNV Recognized as a Notified Body for IVDR Certification

DNV, a leading independent assurance and risk management provider headquartered in Oslo, Norway, has received official recognition from the European Commission as a notified body for certification in accordance with the new In Vitro Diagnostic Regulation (IVDR). This recognition is a significant step forward in increasing capacity for certifying in vitro diagnostic devices, thereby expanding market access within the European Union under stringent new regulations.

The IVDR, which replaced the older In Vitro Diagnostic Directive (IVDD), was introduced to bolster the regulatory framework surrounding medical devices utilized for diagnostic purposes. These devices range widely in application—from standard pregnancy and cholesterol testing to sophisticated diagnostics for conditions such as HIV and cancer. Thus, ensuring the safety and effectiveness of these diagnostic tools is vital for public health.

What is the IVDR?

The IVDR was established in May 2017, emphasizing a robust regulatory approach to the safety and effectiveness of in vitro diagnostic devices. A critical aspect of the IVDR is its classification system, which places diagnostic products into various risk categories. Notably, Class D devices, which have the highest risk, will require IVDR certification starting in May 2025. Furthermore, Class C and Class B devices will follow in May 2026 and May 2027, respectively.

With DNV's designation as a notified body, there is now increased capacity for the certification of these devices, thus aiding more manufacturers in entering the EU market. DNV’s digital certification process is designed to expedite this approval, allowing manufacturers to manage necessary documents online while tracking compliance status in real-time through its secure platform.

DNV’s Role in the Certification Process

Cecilie Gudesen Torp, Global Director of Medical Services, Supply Chain & Product Assurance at DNV, commented on the importance of their new designation. With a rich history of providing reliable certification services, DNV stands out as one of the top five notified bodies for medical device certification globally. The organization combines extensive expertise with technical competence, providing essential support for manufacturers seeking swift market entry.

DNV's multidisciplinary team, consisting of auditors, technical assessors, and clinicians, is well-positioned to deliver efficient and trustworthy certification processes. By minimizing risks associated with diagnostic devices, DNV helps ensure that high-quality products reach healthcare providers and patients faster than ever.

Conclusion

As the healthcare landscape continues to evolve, the recognition of DNV as a notified body under the IVDR signals a commitment to enhancing the safety and efficacy of diagnostic tools available to the public. This development not only improves access to the EU market but also assures manufacturers that they will receive timely and transparent guidance throughout the certification process. DNV is enthusiastic about collaborating with diverse manufacturers across all classifications of in vitro diagnostic devices, aiding them in navigating the complexities of compliance and market access. Through this initiative, DNV emphasizes its dedication to advancing healthcare quality and maintaining the highest standards in medical device certification.

For further information about DNV and its certification processes, visit their official website.