New EU legislation on its way

On June 19th 2015, the European Council agreed the substance of its negotiating stance on two draft regulations aimed at modernizing EU rules on medical devices and in vitro diagnostic medical devices. This was a step towards providing the presidency with a mandate to start their discussions with the European Parliament, with a view to reach an agreement as early as possible.

In the mean time, following the partial agreement in June 19, the European Council has made some technical corrections to their agreed texts.

The Council Workgroup as well as the Parliaments rapporteurs and shadow rapporteurs have started to prepare for their positions in the trilogue negotiations.

Some of the aspects in the debate are relatively new, such as the grandfathering options and the selective assessment schemes for products already on the EU market.

The sessions started mid-October, with 3 meetings conducted and 3 scheduled at this stage: two in November and one in December. Significant preparation has gone, and will go into each of these sessions, the first of which concentrated on chapter I and Annexes I-V of both MDR and IVDR.

Luxembourg, the current chair of the European Union, is striving towards finalization. The further key issues prone to compromises are the following:

  • clinical studies versus literature
  • scrutiny process
  • notified bodies and their supervisory structures
  • reprocessing of single use device

Assuming a positive scenario, legislation may be finished towards the middle of 2016.