- The majority of diagnostic companies reported in a recent survey that they are familiar with the European Union's In Vitro Diagnostic Medical Device Regulation (IVDR), but most are still in the process of implementing the new regulations. The survey of 45 companies was conducted by German software company Climedo Health and contract research institute TRIGA-S Scientific Solutions.
- The survey, which was released Tuesday, showed that 85% of respondents are in the process of IVDR implementation, 11% have not yet started on implementation and 4% are already compliant. Meanwhile, 60% and 27% of respondents said that they are familiar or very familiar with the requirements, respectively.
- Companies reported that timelines, performance requirements and post-market requirements were their biggest challenges as next month's start date for the IVDR approaches. Despite the ongoing challenges in implementation, respondents indicated that the IVDR will improve patient safety, create better traceability of devices and increase transparency over the long term.
The EU's new IVDR requirements are set to take effect May 26 with a staggered rollout, following concerns that the system was not ready to handle full implementation of the requirements and, possibly, risk a device shortage.
The staggered rollout gives certain manufacturers more time to comply with the new rules and have products reviewed by notified bodies. For example, manufacturers of higher-risk devices, such as tests for HIV and hepatitis, have until May 2025 to comply, while the deadline for manufacturers of lower-class devices like an influenza test have until May 2026. Others have as far out as May 2028 to comply depending on other parameters.
One concern has been that the regulations are taking effect without an adequate number of notified bodies, which assess products before they can be marketed. Climedo's recent survey showed that some companies are still struggling to get a notified body.
Forty-three percent of respondents said that they do not yet have a certified notified body, and finding one was the fourth challenge listed in the survey. Half of the respondents said that they have a notified body, and 7% said that it was not required.
A recent report from the European Commission showed that notified body capacity for in vitro diagnostics may still be a challenge going forward.
Respondents to Climedo's survey said that time and staff are the largest needs to be prepared for IVDR implementation, followed by money, notified bodies and regulatory guidance.
At the same time as transitioning to a new regulatory framework, companies have also been managing the coronavirus pandemic. However, 60% of respondents said the pandemic had no effect on their IVDR implementation; 36% of respondents said the pandemic had a negative effect on implementation and 4% said there was a positive effect.
Forty-five in vitro diagnostics manufacturers participated in the survey. The respondents represented all device risk classes and the majority had less than 50 employees. Sixty-seven percent of the respondents were from Germany, 18% from the EU and 15% were from non-EU countries.