Recognition of DNV as an authorized body for IVDR certification announced
DNV Offers Faster, Transparent Device Certification Under New EU Regulations
The European Union (EU) has introduced stricter regulations for in vitro diagnostic (IVD) devices, with the In Vitro Diagnostic Regulation (IVDR) coming into effect in 2017, replacing the previous In Vitro Diagnostic Directive 98/79/EC (IVDD). One company at the forefront of helping manufacturers navigate these changes is DNV, a global assurance and risk management provider.
Under the IVDR, devices are classified according to their risk to public and personal health, with Class D devices, the highest risk, requiring certification from May 2025. Class C devices will need certification from May 2026, and Class B devices from May 2027. DNV aims to reduce risks and help manufacturers get to market faster through its fully digital process for device certification.
The key changes and requirements for IVDR certification include more stringent classification rules, mandatory involvement of Notified Bodies for higher-risk devices, enhanced technical documentation and performance evaluation, and new timelines for transitioning legacy devices from the previous IVDD directive to IVDR compliance.
Stricter Device Classification and Notified Body Involvement
Devices are classified into Classes A (low risk) through D (high risk) with corresponding conformity assessment requirements. Class B, C, and D devices require audits of the quality management system, technical documentation assessments, and, depending on the device, additional expert consultations. Notified Body engagement is mandatory for these higher-risk classes to review conformity and issue CE certificates.
Performance Evaluation and Expert Involvement
The IVDR demands robust performance evaluation reports demonstrating clinical evidence. For Class D devices, designated European Reference Laboratories (EURLs) may be required to verify performance claims, and expert reviews of performance evaluation reports are mandatory under Article 48 of the IVDR.
Enhanced Post-Market Surveillance and Vigilance Requirements
Manufacturers must implement more rigorous post-market surveillance systems and vigilance processes as required by the IVDR to continuously monitor device safety and performance after market placement.
Registration in EUDAMED Database
Manufacturers, authorized representatives, and importers must register device and economic operator information in the European Database on Medical Devices (EUDAMED), supporting transparency and traceability, including Unique Device Identification (UDI).
Transition Timelines for Legacy Devices
Legacy devices previously certified under IVDD have extended phased transition deadlines to full IVDR compliance depending on risk class: Class D by May 26, 2025; Class C by May 26, 2026; Class B and sterile Class A by May 26, 2027. These extensions are conditional on no significant changes to design or intended purpose post-May 2022 and continued compliance with IVDR post-market and registration requirements.
Labeling and Instructions for Use (IFU)
The IVDR introduces refined requirements for device labeling and IFU, including language, UDI carriers, and CE mark placement to ensure clear communication of device use and safety information.
DNV, among the top 5 notified bodies for medical device certification, 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). The independent assurance and risk management provider has a global team of auditors, technical assessors, and clinicians positioned to deliver efficient certification with uncompromising reliability.
DNV's fully digital certification process allows manufacturers to manage certification documents online and track compliance status in real time via a secure digital platform. The company offers extensive expertise and technical competence in IVD device certification, and is ready to collaborate with manufacturers of all classes of IVD devices to facilitate their access to the EU market.
The safety and effectiveness of IVD devices is crucial to public and personal health. Recently, MRC Holland, a company, has obtained IVDR certification for its newborn screen assay, demonstrating the regulatory basis provided by the IVDR for establishing the safety and effectiveness of new IVD devices.
The European In Vitro Diagnostic Regulation is a significant change in the industry, as mentioned in "Medical Device Manufacturing Insights". 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. As manufacturers prepare for these changes, DNV is poised to support them in navigating the complex regulatory landscape and ensuring compliance with the IVDR.
Cecilie Gudesen Torp, Global Director Medical Services, Supply Chain & Product Assurance at DNV, expressed this sentiment: "A certificate of compliance with the IVDR will be required for most IVD devices to be sold in the EU. DNV is ready to collaborate with manufacturers of all classes of IVD devices to facilitate their access to the EU market." With the new regulatory changes expected in 2024 for Medical Devices and IVD's, as stated in "Insights", DNV's readiness and expertise make it an invaluable partner for manufacturers looking to enter or continue selling in the EU market.
The stricter European Union regulations for in vitro diagnostic devices, known as the In Vitro Diagnostic Regulation (IVDR), have necessitated robust performance evaluations and expert involvement to ensure the safety and effectiveness of these medical devices. DNV, as a globally recognized Notified Body for medical device certification, offers extensive expertise in IVD device certification, ensuring compliance with IVDR requirements.
In the realm of health and wellness, science plays a crucial role in the development and approval of medical devices, with the IVDR demanding extensive technical documentation and performance evaluation reports for device approval. DNV's digital process for device certification aims to streamline this process, making it easier for manufacturers to navigate the regulatory landscape and bring their medical devices to market in a timely and transparent manner.
