The medical device regulatory office for the European Commission (EC) finalized a guidance for risk categorization of in vitro diagnostics (IVDs), but concerns about the related implementation date persist. Despite the fact that the original implementation deadline was suspended for a year, many of the affected parties are arguing that industry needs at least another year to implement the new regulations because of the impact of the COVID-19 pandemic on the IVD ecosystem in Europe.
The Nov. 13, 2020, risk classification document by the EC’s Medical Devices Coordination Group (MCDG) employs a four-tier risk scheme, with class D the highest risk category per the manufacturer’s statement of intended use. Any software used with an IVD would necessarily fall into the same risk category as the device with which the software is used.
Despite that the implementation date for the overall IVD regulation has already been suspended for a year, MedTech Europe preemptively argued in July that a number of crucial elements in the regulatory ecosystem are not yet in place. Among the missing building blocks cited by MedTech Europe is a body of guidance documents that are up to the task of explaining the regulations, but the association also noted that there is an insufficient number of notified bodies to handle the impending volume of test recertifications.
Serge Bernasconi, CEO of MedTech Europe, stated that the diagnostics industry is still committed to assisting in the effort to recover from the COVID-19 pandemic, but said the impact of the pandemic on the IVDR implementation “has been considerable, and this must be neither underestimated nor ignored.” In an attached position paper, MedTech Europe called for a delay beyond the existing implementation date of May 26, 2022, but offers no specifics regarding the term of any additional delay.
Ambiguity in Intended Use a Possible Problem
The document is divided into seven rules for risk classification, such rule 2, which covers devices intended for use in blood grouping. Product labeling should clearly spell out the intended use of the diagnostic and the related risk classification, and any ambiguity on this point may lead to a higher risk classification than that proposed by the test maker. There is also some variability within tests for a specific biological agent. The guidelines state, for instance, that a screening test for syphilis would likely fall into class D, but a test to diagnose syphilis in the individual is more likely to be deemed a C risk device.
The guidelines are intended to apply uniformly across technologies, although two tests using the same specimen type may or may not be deemed to fall into the same risk classification. Tests and any associated devices, including software as a medical device, that are used to detect exposure to or the presence of a transmissible agent in the blood, blood components or other organs would be class D devices when those tissue products are intended for transplant, transfusion or administration of cells for therapeutic uses. However, a class D designation might not attach to the same test for such pathogens when conducted for other purposes.
Also among the rules listed in the guidelines are those for devices for self-testing and tests for sexually transmitted diseases. Companion diagnostic tests would fall under class C, as are tests to determine the stage of the disease. Conversely pregnancy tests and tests for fertility are slotted into class B. The guidelines provide classification for instruments, reagents and calibrators as well. Test developers will be liable for annual surveillance assessments for class C and D tests, but not for class A and B tests.