The COVID-19 pandemic has greatly impacted the IVD industry, including travel and social distancing restrictions, creating hassles and stalling NB designation processes.
Recently, the European Commission (EC) announced the designation of a fifth notified body (NB), TÜV Rheinland, for the European Union In Vitro Diagnostic Regulation (IVDR). This is exciting news for manufacturers hoping to comply with the new regulation, which goes into effect on May 26, 2022. The IVDR brings significant changes to the IVD industry with CE certification by an NB now becoming the rule rather than the exception.
The COVID-19 pandemic has greatly impacted the IVD industry, including travel and social distancing restrictions, creating hassles — such as the pause of on-site assessments between mid-March and mid-July — stalling NB designation processes. With less than two years to the date of application, only five IVDR NBs — compared to 21 under the IVDR’s predecessor, the In Vitro Diagnostic Directive (IVDD) — are operating. Further, the number of NBs will decrease by one, as BSI UK will lose its EU designation at the end of this year.
With TÜV SÜD Product Service being the first, and only (as of Dec 3), EU NB to issue an IVDR certificate to a medical device, the IVD industry as a whole is lagging behind to meet quickly approaching deadlines. Other ongoing disruptions continue to affect the medical device industry regarding device design timelines, manufacturing capabilities and distribution logistics.
Understanding the recent guidelines, alternative solutions and best practices in selecting and managing NBs, as well as navigating the lack of on-site audits, can allow continued availability of safe medical devices and assist in preventing medical device shortages.
Rising IVDR bottlenecks amid travel restrictions
The IVDR introduced a new classification system resulting in IVDs now being categorised into one of four groups, from class A (low risk) to class D (high risk). The broadening scope of the rules means that approximately 90 percent of IVDs will now be required to be reviewed by an NB, further adding burdens on and creating a bottleneck for NBs. In one example, under the previous directive, companion diagnostics, classified as low-risk, were self-declared without assessment by an NB. Under the IVDR, companion diagnostics are classified as a higher-risk, Class C device, requiring submission of clinical evidence and a greater scrutiny of data.
These additional challenges to the NB reviewing process magnify the need for companies to start 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 should act as soon as possible before risking the possibility of being too late to achieve compliance.
Further adding to bottlenecks include the decline in the IVDR designation of NBs, which may have been caused by the rise in expectations and responsibilities, the need for more experts to achieve designation and the investment required to train new staff. Even though only five NBs have been designated for IVDR, a total of 15 applications have been received by the EC (at the end of October 2020).
Moving forward, debates over other changes continue, such as loosening on-site audit restrictions. Allowing NBs the freedom and flexibility to conduct virtual audits, for example, has the potential to ease the bottlenecks the industry is experiencing due to social distancing and travel ban hurdles that often prevent on-site visits. However, while the industry is pushing for such changes, regulatory authorities have resisted the idea of approving virtual audits or even extending the 2022 IVDR deadline.
Complicating matters is the fact that — coupled with the IVDR — the Brexit transition period ends in December 2020, and the Medicines and Healthcare products Regulatory Agency (MHRA) has recently issued post-Brexit guidance on IVD in the UK. This is expected to further impact IVD developers. Therefore, they should anticipate more guidance documents and delegating acts to be published, which may cause additional changes.
Building a strategic plan for 2021
While challenges remain, IVD manufacturers should not anticipate the implementation of the IVDR will be delayed. Under the circumstances, they must start prioritising product portfolios and conducting their assessments now to ensure compliance. Moreover, to maintain market share, manufacturers will need to address new clinical data and technical file requirements to ensure compliance in time for the approaching 2022 deadlines.
For more information, read our IVDR white paper: “The IVDR Journey: A roadmap to meet 2022 deadlines, while navigating pandemic disruptions.”Download the whitepaper