this-trilogue-will-finish-somehow-sometimeWith the end of the political year in Brussels in sight I though it would be a good idea to give you an update on process (if you can call it that) in the trilogue for the MDR and IVDR.

Work on implementation by delegated and implementing acts

Let’s start with the good news:  a lot of work is going on behind the scenes with regard to implementation: the delegated and implementing acts. The Commission seems to have realized that there are a lot of those acts needed to even make the regulations work at the date of entry into force (see here for my analysis). The Commission has admitted that they have limited capacity and can churn out about five of them per year, so preparation seems to be key. So far the Commission has been denying that they were working on these acts because the legislative process was not finished yet.

Trilogue will likely not complete this Presidency

It seems more and more that likely by now that the parties in the trilogue will not be able to arrive at an agreement that would allow a final text to be published during or right after the Dutch presidency first half of 2016. The Parliament and the Council still have differences of opinion that are are still very pronounced.

Also, as I have blogged before, the member states themselves are not a united front with especially Germany trying to secure its points (like reprocessing, which many other member states are less enthusiastic about). The other member states are under pressure from their capitals to come up with results in this legislative dossier.

The process runs on two levels, political and technical. The pace, especially during the technical meetings, is said to be very low.

A problem with the trilogue negotiation process is that nothing is finally agreed until everything is agreed, which means that results that have seemingly been reached can shift all of a sudden. At the end of the negotiation each party will take stock of whether they have scored enough points and can always revisit points when they feel that they came up short. This is why the outcome of the trilogue is always difficult to predict. The Luxemburg presidency had organized the trilogue in four blocks with a decision to be taken at the end, but sources close to the process tell me this is not going to happen before the Christmas holidays. The Dutch presidency is now planning to finalize the trilogue and has already planned for that. That means that the latest planning of a final text end of the first half of 2016 will move up 6 months at least. That means that there seems to be extra room for lobbying on the dossier.

Remaining political issues

What makes that the trilogue progress so slow and contentious? There are still many issues that the member states and the Parliament see as political points. The most important remaining political issues that draw out the process seem to be (see also my previous post):

  • genetic testing (mainly IVDR rapporteur Peter Liese’s plan to do something with lifestyle tests, which was never constitutional in the first place)
  • CMR substances (the Parliament is intent on doing something to make the MDR and IVDR look more environmentally and patient friendly by banning CMR substances even if this is already covered under other EU legislation and regardless of the risk/benefit ratio of individual devices that depend on the use of such substances)
  • reprocessing (Germany wants this, the Parliament may want it less now than under the previous rapporteur Roth Behrendt (“single use labeling is like printing your own money“) and many member states do not want it)
  • (mandatory) liability insurance of the manufacturer and authorized representatives (the current proposal flies in the face the face of the Product Liability Directive in every way)
  • scrutiny / special notified bodies
  • transitional periods (member states seem to start to realize that the transitional periods for both regulations will ‘interesting’, although the three years for the MDR is not up for discussion – it seems likely that a solution will be found in the duration of certificates granted under the old rules (currently max 2 years after end of transition period). This makes it more and more important for manufacturers to set up a good plan on when which of its devices transition to the new regime).
  • classification rules (rules 6 (reusable surgical instruments automatically class I), 19 nanotech (new, so scary and therefore risky) and 21 substance based devices (all in class III))
  • clinical investigations / clinical performance studies (especially with regard to IVDs the clinical endpoints that studies have to prove are not agreed yet)
  • in-house manufactured medical devices (Parliament does not like it, while member states see possibilities because they have hospitals)
  • resources at member states and notified bodies (currently the EU notified bodies combined have about 100 people qualified for IVDs, which would need to process all IVD certifications coming out of the quantum leap (80% to 20% self-certified IVDs) – this will be not be possible)
  • etc.

Now what?

I think we should slowly start to get used to the thought that we will not have new regulations around the middle of 2016, but at best towards the end of 2016. Unless, of course, a miracle happens.