Interesting developments in the IVDR field, as the approach taken by companies often deviates from the approach by companies working towards MDR compliance. And there is some logic to it. After all, the impact and sheer volume and width of the changes in the IVD field require a reboot on thinking on products and portfolio, other than MDR that is ‘merely’ adding stricter rules of compliance to basically existing elements such as PMS, PMCF and clinical data generation.
In the IVDR the changes are more fundamental, and with completely overhauled risk management basis, notified bodies involved with most products whereas historically they were not, and with a new burden to prove the relevance of the diagnostic outcome of tests, a regulatory revolution actually is what we have in front of us.
To give you an impression on the type of discussions that are taking place, think of the following examples:
These products currently are being used, and pharmaceutical companies in most cases provide the validation results of such test to establish the usefulness of a specific drug for a specific patient as part of the eCTD dossier for their new drug. Drug agencies review them to some extent, and approve the test as accessory to the drug. One can argue if that is correct, or if they already should fall under IVD Directive at this stage. But clearly, they will fall explicitly under the IVDR in the future. Mentioned specifically as class C product they would require a notified body technical documentation review and conformity assessment, and part of the assessment is a consultation with a drug agency. More work in a way, and potential delays in market approval on the one hand, but on the other hand also opening up the field for generic tests by other manufacturers than the pharmaceutical companies themselves. But the cumbersome regulatory path is initiating a new debate: what if we change the claims and make them more generic, in which case the test might be a regular IVDR product, so not a companion diagnostic. Will that be feasible? At least for a few years until we find in PMS that the test is also used as companion diagnostic? But it might buy us some time to get our data fully in place.
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RUO: is it truly disappearing?
Many products in the IVD domain have been marketed in Europe as Research Use only, or with the wording that it cannot be used for diagnosis of patients. In reality, many hospitals used them for diagnostic purposes in their daily work, or they built in-house kits from the research reagents provided. Questions and discussions focus on the future of such devices. Will more of them have to be seen as being covered by the IVDR? If we simply but strictly follow the current MEDDEV 2.14/2 rev.1 from 2004 that currently is in place and instructs is to only allow sales of RUO when no patient will be analysed with it. Can we control this sufficiently? Will there be escapes from IVDR in the future, and can we rightfully exploit them. What effect would that have on indications for use, on claims, on PMS? Is the latter applicable?
Instruments as class A, or can we move them to B, C, and even D?
Classification rule 5.b seems to clearly spell out that “instruments intended by the manufacturer specifically to be used for in vitro diagnostic procedures” are class A. Yet that might be not so black and white, as at this stage debates are ongoing to verify if this really was the intent. If we look carefully at the wording in other rules, we might have to discuss if the wording “device intended to be used for….” could be regarded to also cover instruments that are specific for these specific tests and detection methods.
Just a few examples to illustrate the point. Where MDR moves on from MDD, and manufacturers are starting to implement, based on years of discussion on intent and expectations held during the legislative process, the changes in the IVDR and their potential impact are so fundamental, it requires further debate now that the latitude of the revolution in the regulatory landscape is slowly dawning.
For IVD’s the traditional start of a GAP analysis to estimate the impact of changes seems not to be the ideal start for the IVDR implementation. Before the GAP analysis is started, there needs to be a regulatory strategy discussion to discuss the fundamentals of the new IVDR. These strategic discussions should lead to several routes and alternatives applicable for the specific IVD. Once the strategic direction is set, the GAP analysis can start.