LS&HC Horizons 2023 - Flipbook - Page 14
Hogan Lovells | 2023 Life Sciences and Health Care Horizons | Clinical Trials
14
Companion diagnostics and IVD in drug/pharma clinical trials in the EU
Many drugs are developed for use in very
specific patient populations. In trials, these
patients are often identified by way of in vitro
diagnostic (IVD) assays. Further, IVDs are
often used to define intervention (treatment)
in trials or to evaluate endpoints.
The strict IVD Regulation (IVDR) of the EU
basically says: If the assay is an IVD medical
device, it needs either a CE marking for
its specific purpose within the trial (often
not possible yet), or it must be used as an
investigational device. In the latter case, the
drug trial requiring an IVD would also need
to be set up as a performance evaluation of
such IVD, i.e., as a device trial. Then, (often
different) competent authorities require: two
separate trials with two different separate sets
of requirements. This separation applies even
if the assay is a “companion diagnostic”, i.e.,
one which is essential for safe and effective
use of the drug. The current Medical Device
Coordination Group (MDCG) Guidance 202210 on the interface between the Clinical Trial
Regulation (CTR) and the IVDR deals with this
situation to some extent.
Dr. Jörg Schickert
Partner, Munich
It says: If an IVD is solely used for retrospective
testing of endpoints, it is not subject to the
IVDR. The reason: no medical purpose!
It does not say specifically: Even if the assay
has a medical purpose (namely, it determines
patient eligibility for a trial or later trial
treatment) there are alternatives to conducting
an IVD performance evaluation within the
drug trial:
• In our view, pure and simple laboratory test
methods may not even be IVD, let alone
medical devices, and may thus not be subject
to the IVDR at all.
• If the assay is an IVD medical device, it may
well qualify as so-called in-house testing. For
such testing, many requirements of the IVDR
are waived. The term “in-house testing” may
sound narrow. However, in many cases even
IVD testing performed in EU labs which are
different from the site/health institution
which collects the samples can be considered
in-house testing.
Dr. Benjamin Goehl
Senior Associate, Munich
