After endless delays and setbacks, the European Council has agreed on a partial approach on the Medical Devices Regulation.
The European Council is a co-legislature with the European Parliament and as such, both sides must agree on the final text of the Medical Devices Regulation (MDR). A pre-requisite for negotiations (trialogues) to take place however, is that both sides must have a position. The European Parliament has had a position since April 2014. Over a year later the European Council has finally made some headway and have agreed a partial approach with certain details put on hold for a later date so that trialogues can begin.
Under the mantra ”Let’s not make the best the enemy of the good”, most delegations (with the exceptions of Germany, Poland and Czech Republic) have agreed to move to the next stage, despite not fully agreeing with the outcome on some elements on the general approach.
The most controversial topics are still the premarket assessment of high risk devices, reprocessing, inclusion in the scope of the legislation of aesthetic products and the unique device identification system, which will constitute the main subjects of discussion in the trialogues ahead.
Trialogues are due to begin in September 2015 but it is unclear whether agreement between the two institutions can be reached before the end of the year.
The full text of the partial approach, which is more of a “permission to proceed” document, can be found here.