More on scrutiny in the general approach proposals for medical devices and IVDs
Upon closer examination of the two texts for the MDR and IVDR it became clear that the scrutiny proposals in both regulations are actually identical (sorry for the earlier confusion).
Accordingly, there are two novelties.
Largely the same
First, things unexpectedly stay largely the same both under the MDR and IVDR: pre-market evaluation by a notified body and post-market controls by the authorities. This is definitely a novelty because this was not the expected outcome.
The member states have apparently been able to agree that the current quick market access procedure in the EU has served the market very well and that a more front loaded pre-market process does not produce safer devices, as has been recognized also in pharma market access.
Of course we will need to see if this holds up during the trilogue with the Parliament.
Validation of clinical strategy by expert panel
Secondly, the novelty in the market access procedure for medical devices is the possibility for class III devices manufacturers to submit their intended clinical development strategy and proposals for clinical investigation(s) to an expert panel for consideration (article 49 (1a) MDR).
The only disincentive to do this is that on the one hand the manufacturer shall give due consideration to the views expressed by the expert panel and must document the panel’s considerations in the clinical evaluation report, while on the other hand the manufacturer cannot may not [that’s what the text says] evoke any rights to the views expressed by the expert panel with regard to any future conformity assessment procedure.
While a notified body can diverge from the expert panel findings later in the conformity assessment procedure, it has to provide justification for this when it notifies the certificate and this is basically the only guarantee that the manufacturer has that the notified body will follow the clinical strategy validated by the expert panel.
Yet, this is an improvement over the current situation where I regularly see notified bodies move the clinical goalposts after the notified body has agreed with the manufacturer on a clinical strategy and even after the manufacturer has already started trials based on that agreement. This puts especially start-up companies in sometimes extremely problematic situations, e.g. when they lack funds to perform the additional trials and go bankrupt.
It would be nice if the expert panel’s evaluation of the strategy would carry more mandatory weight for the notified bodies, because it would make relying on it more attractive for the market, which will lead to a harmonization of clinical evidence for class III devices that everybody should want, including manufacturers (as they hate to see competitors with a better deal on clinical evidence for the same product).