White smoke: we have a general approach for the medical devices and IVDs regulations

Schermafbeelding 2015-06-21 om 19.28.23

Yes, finally!

Yes we can! We have a general approach for both the Medical Devices Regulation and for the IVD Regulation, agreed in the EPSCO Council last Friday.

The press release also conveniently bundles all the general approach texts.

Although the Council statements by the member states during the meeting left a lot of question marks as to what was going to happen, the Council still managed a partial general approach in the end.

The general approach is partial because the Council still has not agreed on the recitals to the regulations and there are still some technical inconsistencies to be ironed out. If you are interested in the full debate, here is the video of the whole session.

The Latvian presidency was visibly relieved at the end of the meeting, having finally crossed the finish with its wheelbarrow of frogs. That doesn’t mean that everybody was happy though.

Cost and complexity

One of the general concerns that was consistently voiced were the costs and complexity of the system set up with the compromise, and the need to keep that under control. It’s interesting how politics always seem to take place in a universe parallel to reality, because this is something that industry has been raising awareness about for almost three years now. I guess it seems more opportune to first set up a complex and costly system while ignoring signals to the contrary before starting to wonder whether the system is not getting to complex and expensive, and then be forced to deliver a system validated only by confirmation bias.

MedTech Europe, important voice of the EU medtech industry, was not completely happy with the results, flagging a number of points in both regulations that will still need work in the trilogue (see here for more detail):

  1. the scrutiny mechanism (still too complex and too slow);
  2. reprocessing of single use devices (different levels of safety depending on who is the reprocessor (original manufacturer, commercial reprocessor or hospital reprocessed));
  3. clinical evidence for IVDs (clinical evidence burden raised too much compared to Commission proposal); and
  4. companion diagnostics definition (too broad to be functional)

Several member states also made it clear that while a compromise was reached because they wanted to be ‘constructive’ but not because it made them happy so that they will still push the points that they were not happy with.

Peter Liese, the rapporteur for the IVD regulation was not happy either and stated in the mean time that the Parliament thinks that the Council’s text needs improvement and still seems to stick to the unconstitutional genetic testing proposal.

Unhappy member states and unhappy Parliament means that the Parliament and the member states concerned may seek to exploit the loose ends in the negotiations that follow in the trilogue and may form (unexpected) coalitions to score the occasional points in the political process where there is overlap.

What’s next now?

According to the Council’s press release:

“The agreement on the substance of the Council’s negotiating stance will allow the next presidency to take contact with the European Parliament to prepare negotiations between the two institutions. Once the Council has finalised some outstanding technical work concerning the preamble of the two draft regulations, negotiations between the institutions will be able to start.”

For the subsequent timeline see my earlier blog on the MDR text. There are no indications as yet that this would change.


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