EU flagWith this post I would like to make good on a promise I made some time ago: that I would also do an analysis of the proposed IVD Regulation in more or less the same level of detail as I did for the proposed Medical Devices Regulation, so here we go.

As a starting point, you should keep in mind that the Medical Devices Regulation and IVD Regulation proposals overlap to the point that the Commission has seriously considered merging them into one regulation, but in the end refrained from doing after considerable lobby from the IVD industry that IVDs are too different to be in the same regulation. Therefore, basically all of the procedure stuff I wrote about in previous posts on the Medical Devices Regulation proposal will apply to IVDs as well because it is mirrored in the IVD regulation proposal.

Another point to remember is that as a result of the implementation of a GHTF risk based classification mechanism the large majority of IVDs must be looked at by a notified body, which is a landslide difference with the current situation (see slide 5 in the presentation below).

If you want the whole story, I did this presentation as a webcast for RAPS on 3 April. If you would like the full story, your best option is to purchase the webcast from RAPS. A condensed version of the slides is here:

Compared to Sabine Oshe’s presentation that I wrote about before there is not that much difference. I have tried to provide more detail on some additional things that are really new in IVD regulation, so here’s a small gap analysis for the items that feature additional detail:

  • the GHTF based risk classification
  • the qualified person
  • parallel trade and repacking provisions
  • the scrutiny procedure (“It’s a trap!”)
  • interventional clinical performance test regime
  • market surveillance
  • more detail on the governance via the MDCG and reference laboratories; and
  • explanation of the transitional regime

Of course everything that I wrote about the PMA controls that the ENVI committee of the European Parliament may require applies as well with respect to the IVD regulation – assuming however that the ENVI committee will treat all medical devices the same. So far there has been very little to no discussion of PMA with respect to IVDs, while also the highest risk class of IVDs are subject to the scrutiny procedure that the ENVI committee considers insufficient pre-market control for high risk medical devices.

With IVDs the discussion has so far concentrated on ethical and privacy aspects of genetic testing, which are perfectly justified concerns. The level of discussion has been disappointing at times. My personal impression is that people are scared of things they don’t understand and have been depicted in a scary way in science fiction movies, so I think it’s time to educate the public on risks and benefits of technology rather than kill innovation by imposing rules that make no sense because people are scared of complex stuff they don’t understand. It all comes down to the technology safety versus security discussion that I have raised earlier. Hey, this scary stuff is only science fiction, fiction being stuff that is made up . Indeed, genetic testing is a necessary technology to reap the benefits of personal medicine and most people would like a cure for their cancer, don’t they? I do, in any event. Just like Eric Topol, I’m more than a glass half full type of guy when it comes to this kind of possibilities. IVDs are the parent of healthcare after all, and data is key to this industry.

These discussions also have a place in the discussion regarding the General Data Protection Regulation (GDPR) proposal, which has a special regime for ‘genetic data’ that is separate from the regime for ‘data concerning health’ with an overlapping definition. This is quite unfortunate, because under the GDPR proposal ‘genetic data’ and ‘data concerning health’ are subject to – yes indeed – separate control regimes. While there seems to be some movement in amending the definition of genetic data (which in its first draft even included non-personally identifiable genetic data, so in fact data outside the scope of the regulation), I have not seen any movements by the ENVI committee to untie the gordian knot of the overlap of these concepts so this will remain problematic: what genetic data constitutes health data and what does not?

If you want to know more, EDMA has scheduled a workshop on the IVD regulation proposal in Brussels, somewhere in June with timing understandably depending on political developments with the proposal so watch that space.