Günter Weisshaar, senior vice president, global head of quality, regulatory affairs and operational excellence, Tecan, outlines the latest challenges facing companies as a result of IVDR.
The In Vitro Diagnostics Regulation (IVDR) was established to update the existing European Union in vitro diagnostic (IVD) device regulations. This article discusses the significant changes, challenges, and benefits it brings, and how the industry can ensure IVD devices are – and continue to be – compliant as the next implementation deadline approaches.
The need for a major regulatory overhaul of pre- and post-market requirements for IVD devices led to the implementation of IVDR in May 2017, with a five-year transition period, initially ending on the 26th of May 2022. This ‘grace period’ gave companies time to ensure compliance with the new regulation, which is more stringent than its predecessor. The already tight timeline became even more challenging when the COVID-19 pandemic struck, forcing companies to change priorities and divert resources to fight the virus. The result was a European Commission proposal for a more progressive roll out, to avoid disruption to the supply chain of essential healthcare products. While new IVDs and Class A non-sterile devices must still comply with the IVDR from May 2022, other device classes and in-house assays will benefit from a more gradual implementation between 2025 and 2028. This proposal was accepted by the European Parliament and European Council, and the amended regulation was published and entered into force on the 28th of January 2022.
The new requirements
IVD devices will now be classified according to four risk classes, ranging from class A (lowest risk) to class D (highest risk). Previously, only around 20% of IVD devices needed notified body (NB) approval, with the majority benefitting from self-certification by the manufacturer. Under IVDR, however, approximately 80% of devices will need some level of NB oversight, which will apply not only to bringing the product to market, but also throughout its entire lifecycle to ensure continued compliance. Post-market surveillance of devices will demand that manufacturers update technical information to enable continuous evaluation of new hazards. As technology evolves, risk profiles and product performance studies may need updating to retain certification, for example, to account for changes in antibiotic resistance, new interfering substances or variations in stability profiles.
The previous directive was launched in 1998 and, consequently, it does not cover several of the innovations and novel techniques developed in the intervening period. IVDR was initiated to address this, and comprises comprehensive coverage of new technologies, including next generation sequencing, point-of-care testing, companion diagnostics and medical software. This ensures that techniques and technologies recently brought to market are both clinically relevant and safe for the patient. The IVDR also tightens the rules regarding technical documentation and clinical evidence. Legacy data may no longer be sufficient; additional studies may be required to prove the continued clinical performance and safety of the IVD device.
Rising to the challenge
Manufacturers, particularly smaller companies with limited resources, will feel the impact of the additional time and cost involved to obtain IVD device certification. The increased responsibility to supply technical documentation – both pre- and post-market – might lead to consolidation of portfolios in circumstances where a product is deemed commercially unviable to continue. Subsequently, this could potentially limit the availability of certain IVD devices in the short term. NBs will also be under pressure as they strive to certify the plethora of applications to be submitted, which is already proving a bottleneck in the process.
The entire supply chain – including suppliers, manufacturers, R&D teams, sales departments, and distributors – will face increased responsibilities. Companies will be required to know exactly who contributed to the development of the product, helped bring it to market, and kept it there throughout its entire lifecycle. Although this will provide greater transparency along the supply chain, it is far more labour intensive, leading to increased costs and slower certification if a company isn’t fully prepared. Manufacturers will also have to share more information with OEM customers, as the IVDR requires the provision of technical documentation on the IVD device.
Making the transition
Preparation is the key to successfully navigating the transition to the IVDR, starting at the earliest possible opportunity. At Tecan, this meant close adherence to its recommendation to ‘plan, engage and communicate’, beginning immediately after publication of the IVDR. This included changes to the quality management system and supply chain appraisals for each IVD product, as well as a thorough portfolio review and gap assessment of technical files. The company approached NBs at an early stage, arranged quality system audits, clarified product classifications and groupings, and developed a submissions roadmap. Clear communication with all internal and external stakeholders throughout the entire process proved essential, both to guarantee consistency across the board and to manage expectations. Following a similar framework is the foundation to help with the timely approval of any IVD device portfolio.
The new IVDR was established to raise quality standards and provide confidence that IVD devices are safe, reliable, and fully compliant from the moment they become commercially available. The journey to compliance is undoubtedly taxing and has proved a steep learning curve for the entire industry. Therefore, working together and supporting each other is vital. Larger companies, such as Tecan, need to share experiences with their partners, so that they can learn from the challenges and mistakes encountered along the way. This collaborative approach is particularly important for smaller companies, which play a crucial role in the development of innovative devices but may not have the resources to complete the required work for IVDR certification. The support of large partner corporations will help to drive the IVDR pipeline, safeguarding the ongoing development of healthcare products that truly make a difference.