Tuttlingen – The EU Commission's legislative proposal to adapt the MDR transitional provisions for certain medical devices is to be voted on this week. An important step that must not be the last, comments Julia Steckeler, Managing Director of MedicalMountains GmbH.
At its session on Tuesday, the European Parliament approved the proposal “amending Regulations (EU) 2017/745 and (EU) 2017/746 with regard to the transitional provisions for certain medical devices and in vitro Diagnostics” to be dealt with in an emergency procedure. Thanks to the “Urgent Procedure”, the final vote can be made within a few days. However, that is not the end of the work.
“You have certainly followed the developments surrounding the EU Commission’s legislative proposal to adapt Regulation (EU) 2017/745 (MDR) to the transitional provisions for certain medical devices. The process is now entering the final phase, and one conclusion can already be drawn: work on the MDR system continues.
MedicalMountains GmbH welcomes and supports the decision in principle. We consider it to be an indispensable measure in order to counteract the imminent shortage of proven medical devices in Europe and the associated risk to public health quickly and with legal certainty.
As important as this step of the transition periods is, from our point of view it does not mark the end. Extended transition periods do not solve the structural problems of the MDR, which have led - and continue to lead - to manufacturers discontinuing medical devices, to the fact that small and medium-sized companies in particular, but not only, can hardly afford the approval financially, that innovations leave Europe. These construction sites remain open and we will vigorously advocate closing them in the political dialogue.
In the short term, however, it is now a question of implementing the new transitional provisions and the conditions attached to them in such a way that they are practicable for the manufacturers. To do this, we are in contact with the relevant stakeholders - the Federal Ministry of Health, partner associations, notified bodies and the EU Commission itself. This means, among other things, that no new bureaucratic hurdles are created and clear rules of the game are set for all stakeholders. Otherwise, the time gained threatens to run out faster than it is useful – without even closing one of the other gaps. And nobody can really afford that anymore. Neither manufacturers nor notified bodies, neither the industrial site nor the healthcare system.”
INFO:
The ARD magazine Plusminus recently dealt with the impending shortage of medical products. Among other things, MedicalMountains Managing Director Julia Steckeler has a say. The article can be accessed under this link in the ARD media library.
