- The European Commission has finalized its class D in vitro diagnostic implementing regulation to create common specifications for high-risk devices.
- Moving earlier this year to address the lack of harmonized standards for certain requirements of the In Vitro Diagnostic Regulation, the Commission released for consultation draft common specifications for tests against pathogens such as HIV and hepatitis C.
- While MedTech Europe pushed back against some of the testing requirements, noting that some of the requested samples are very hard to source, the Commission has retained disputed parts of the document.
The document features general common specifications for the class D IVDs, explaining, for example, how to determine performance characteristics and the whole system failure rate as well as the specific steps developers need to take to validate tests against particular pathogens. MedTech Europe sought changes to some of the specific requirements.
“We highlight requirements that are unfeasible to fulfill from a scientific perspective and where certain definitions need to be improved. In particular the number of samples and genotypes required for certain infectious agents, compared to their limited availability. Where samples and genotypes are difficult to source, this may cause interruptions to the market,” the trade group wrote.
MedTech Europe said “it is apparently impossible to obtain genotype 6 samples, that are negative for anti-HCV,” adding that “genotype 4 and 5 seem to be unavailable.” Given the supply difficulty, the trade group asked the commission to focus on genotypes 1 to 3, with the other genotypes used if available.
The Commission retained the requirement to use HCV genotypes 1 to 6 in its sections on the diagnostic sensitivity for first-line assays and antigen tests, although, as in its draft proposal, it permits developers to provide a justification if a genotype is unavailable.
Similarly, MedTech Europe asked for changes to a section on hepatitis B tests because “mutant samples for Anti-HBc are very rare.” The Commission left the section unchanged other than replacing the word “sampling” with “specimen taking.”
The requirements are subject to a transition period. If an IVD conforms to the technical specifications of the old directive or certain parts of the new regulation, European authorities will presume they comply with the new specifications until July 25, 2024, when the transitional provisions will end.