DNV acknowledged as an accredited entity for certification under the In-Vitro Diagnostic Regulation (IVDR)
MRC Holland, a renowned player in the in vitro diagnostics (IVD) field, has recently achieved IVDR certification for its newborn screen assay. This significant milestone increases the capacity for certifying IVD devices and provides manufacturers with easier access to the European Union (EU) market.
The European In Vitro Diagnostic Regulation (IVDR) is undergoing changes, as detailed in "Medical Device Manufacturing Insights". The IVDR, which replaced the In Vitro Diagnostic Directive 98/79/EC (IVDD) in 2017, provides a regulatory basis for establishing the safety and effectiveness of new IVD devices.
The IVDR mandates more rigorous technical documentation, stronger quality management and surveillance systems, adherence to revised certification transition timelines, and compliance with new procedural requirements for notified body engagement and device classification.
Under the IVDR, devices are classified according to their risk to public and personal health. Class D devices, which have the highest risk, require IVDR certification from May 2025. Class C devices will require certification from May 2026, and Class B and sterile Class A devices from May 2027.
DNV, one of 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 IVDR. DNV's global team of auditors, technical assessors, and clinicians are well-positioned to deliver efficient certification with uncompromising reliability.
The designation of DNV as an IVDR notified body brings greater capacity to the certification market, helping more device manufacturers access the EU market. DNV offers device manufacturers a fully digital process for faster, more transparent device certification.
In addition to MRC Holland, DNV is ready to collaborate with manufacturers of all classes of IVD devices to help them enter the EU market. The safety and effectiveness of such devices are crucial to public and personal health, and DNV aims to reduce risks and help manufacturers get to market faster through its certification process.
The text does not provide information on any other IVD device that has recently obtained IVDR certification. However, it is expected that more manufacturers will follow suit as the regulatory changes outlined in the IVDR continue to take effect.
In 2024, there are expected to be significant regulatory changes for medical devices and IVD's, as mentioned in "Insights". Manufacturers must align their internal processes carefully with these updated regulatory expectations to maintain market access in the EU.
[1] Medical Device Manufacturing Insights [2] IVDR: What you need to know [3] IVDR Regulation (EU) 2017/746 [4] IVDR: The new era of in vitro diagnostic medical devices [5] IVDR: Key Changes and Requirements for IVD Certification under the EU's In Vitro Diagnostic Regulation (IVDR)
- The advancements in the European In Vitro Diagnostic Regulation (IVDR) as detailed in "Medical Device Manufacturing Insights" indicate a growing demand for compliance with stricter quality management and safety standards for medical devices, including medical-conditions diagnosing devices like the newborn screen assay certified by MRC Holland.
- In light of the forthcoming changes for medical devices and IVDs in 2024, as mentioned in "Insights", health-and-wellness practices will need to integrate science and technology, ensuring their medical devices adhere to the new regulatory requirements under the IVDR, such as stronger surveillance systems and revised certification transition timelines.
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