Dig into this top-read Genomeweb story that sets the current regulatory scene for EU labs and global manufacturers under IVDR. (Spoiler alert: Platomics receives mention by the end!)
While the good intentions of the IVDR are clear to most, many fear that the complex regulatory work required of diagnostic labs, IVD manufacturers and the few notified bodies so far available to certify products under the IVDR will hamper innovation and the availability of tests for patients.
And indeed, this article quotes both labs and manufacturers that are already feeling the pain one year into fulfilling the first set of requirements, including the General Safety and Performance Requirements or GSPRs.
Labs are weighed down with the paperwork of risk assessment for their in-house tests, for example, or confronting the fact that they are no longer permitted to use “home-brewed” bioinformatics pipelines developed by another lab and “transferred” to theirs.
They are also starting to see some of the products used in their workflows disappear because smaller manufacturers are not willing or able to keep up with the new regulations for the EU market.
It remains to be seen how far such examples of stumbling blocks will continue to mount. What is clear, however, is that the IVDR is here to stay.
And as precision medicine continues to progress, the trend toward tighter regulation of IVDs is now also gaining momentum in the US, with the FDA gearing up to secure oversight of lab-developed genetic tests in a similar fashion.