Angela Brown, global head and senior director, regulatory affairs and Nicole A. Cowan, director, project management, IVD operations & strategy, examine how IVD manufacturers can meet 2022 deadlines despite the COVID-19 pandemic.
The COVID-19 pandemic created an evolving regulatory landscape with protocols and guidelines changing to keep pace with the virus and its impact on the healthcare system. Further, this pandemic affected the medical device industry regarding device design timelines, manufacturing capabilities and distribution logistics.
Particularly, the in vitro diagnostic (IVD) market had to shift quickly with SARS-CoV-2 tests requiring rapid development, leaving global supply shortages and labs struggling to meet demands. Amid these disruptions, IVD developers face the challenge of complying with the new IVD Regulation (IVDR).
The IVDR brings significant changes to the IVD industry with CE certification by a notified body (NB) now becoming the rule rather than the exception. Due to the pandemic, IVD manufacturers must comply with the 26th May 2022 deadline have come up against many challenges such as the lack of NB on-site audits due to travel and quarantine restrictions.
While the industry is pushing for changes — such as the ability for NBs to conduct virtual audits and an extension to the 2022 IVDR deadline — regulatory authorities have resisted. Coupled with the IVDR, the end of the Brexit transition and guidance from the Medicines and Healthcare products Regulatory Agency (MHRA) has further impacted IVD manufacturers.
Understanding the recent guidelines, alternative solutions and best practices in selecting and managing NBs can allow continued availability of safe medical devices and assist in preventing medical device shortages.
IVDR bottleneck grows amid travel restrictions
Under the IVDR, IVDs will be categorised into one of four groups from class A (low risk) to class D (high risk). This new classification system is an enormous change, as broadening the scope of the rules means that approximately 90% of IVDs will now be required to be reviewed by a NB, placing an additional burden on and creating a bottleneck for NBs. For example, under the previous directive, companion diagnostics were considered low-risk and self-declared without assessment by an NB. Now, classified as a higher-risk, Class C device, they will require increased expectations for clinical evidence and a greater scrutiny of data.
The establishment of new classifications provide additional challenges to the NB reviewing process, amplifying the need for companies to go through the certification process early. Given the length of time needed for products under the new regulation — even more so for high-risk diagnostics — to be certified by an NB, companies will need to act as soon as possible before to achieve compliance.
COVID-19 has further exacerbated the existing bottleneck. Before this pandemic there was already a decrease in the IVDR designation of NBs, possibly caused by the rise in expectations and responsibilities, the need for more experts to achieve designation and the investment required to train new staff. However, since the pandemic, no on-site assessments took place between mid-March and mid-July, neither for MDR nor for IVDR, causing delays in the designation process.
As of 24th November, TÜV SÜD Product Service has been the first, and only, EU NB to issue an IVDR certificate to a medical device. With less than two years to the date of application, only four IVDR NBs — compared to 21 under the IVDR’s predecessor, the In Vitro Diagnostic Directive (IVDD) — are operating.
Debates over other changes continue, such as loosening requirements for on-site audits. Allowing NBs the freedom and flexibility to conduct virtual audits has the potential to ease the bottlenecks the industry is experiencing due to hurdles currently preventing on-site visits.
A strategic plan
IVDR is still in its infancy. As such, developers should anticipate further guidance documents and delegating acts to be published, which may cause additional changes. Despite growing challenges, it is unlikely that the implementation of the IVDR will be delayed.
Regardless of current certification under the IVDD, there is no grandfathering. Therefore, IVD manufacturers must start prioritising product portfolios and conducting their assessments now to ensure compliance. While some products can remain on the market via extended compliance with IVDD during a grace period (which lasts until 26 May 2024), for products currently in development and early in the product life cycle, manufacturers should ensure they are working towards IVDR requirements for EU approval.
To maintain market share, manufacturers will need to overcome the shortage of NBs, as well as address new clinical data and technical file requirements. Establishing strategic partnerships can help in creating a global market strategy to ensure compliance in time for the deadlines.