The question I’ve asked myself last week at our 25th Qserve anniversary conference is if we’re standing at the crossroads of implementation in EU MDR and EU IVDR. When listening to the debates during sessions and in the extensive breaks, it appeared to me that many people were talking about the how and were sharing best practices, instead of talking about the why and why not or the not yet.
This was particularly true for the area of data collection and where relevant the supporting data integrity and reliability. People, and with them their companies, are getting into play mode, particularly in the medical devices world, as well as in the companion diagnostics sector. The regular IVD world needs to catch up, as we still hear stories of companies that have not been fully aware of their obligations under IVDR, or at least not to the level that actional projects for implementation could be initiated.
Inspiring was the large number of people who joined the sessions and workshops on running PMCF surveys and studies, as well as those on running various types of pre-market clinical trials. People start wanting to do such data collection, inspired by enhanced awareness of the regulatory expectations, or in some cases further motivated by challenging questions from their notified body. Moving into collecting data in a smart way in PMCF for example might include short-term data collection in surveys to get through the MDR hurdle and more structural solutions on continued data capture for the following maintenance mode. As for clinical trials, lots of discussions to conclude a small first-in-man study might not be enough for certification, but a second study could be needed to ensure the sufficiency of the dataset.
Panel debates circled among others on the criticality of PMCF, as there are no exceptions. Even if you would get an MDR certificate under article 61.10 without clinical data, active PMS and PMCF requirements are in place. Bringing PMCF data back into the “knowns” on our products and reducing the level of “unknowns” in our narrative and in the risk management files is where data should flow. And getting that story integrated into the technical dossier build-up and maintenance is starting to find its way into the regulatory reality.
Also, in the companion diagnostics field, many questions and discussions focus on the (clinical) performance data generation, as in many cases this is linked to the clinical studies performed on the drugs the companion diagnostics are coupled with. Combined trials under pharma and IVDR regimes can be complex, in getting the approvals and splitting out the datasets to also support the individual review of the diagnostic dataset and reliability thereof.
Of particular concern is the more limited attention regulators have for the IVDR, with most guidance first aiming at MDR. Of course, IVDR manufacturers may try to implement a parallel interpretation for IVDR, but that is far from perfect. A specific complexity is that there still is not much noise from regulators, notified bodies, and other stakeholders on the need to collect clinical data and get real-world evidence in pre-market as well as in the PMPF setting.
So, circling back: are we at the crossroads? I think we are. But here are two distinct crossroads. The one for the MDR is uncluttered and clear. Companies know what to do, and the wide road ahead is moving to include clear-structured clinical data, where the emphasis lies on a two-staged approach for immediate data to be used in submissions and for long-term structural data-collection and integration approaches. Some may choose to go left or right, moving into other markets first such as the US, BRICS, and MEA, but many have crossed into the wide road ahead. In IVDR the crossroads appear to be much more cluttered, and many are wondering where to go next.
The good news is that we’re talking and sharing experiences. So, join that debate, and together we can get everyone on their way beyond the crossroads!