Medical Device Directive: state of play and future challenges

The European Institutiohealth monitorns have been working on the Directive on Medical Devices and In-Vitro Diagnostics since 2012. With the adoption of the European Parliament’s position in 2013 and the Council agreeing their approach in October 2015, the process has undoubtedly been slow. It was originally hoped that a conclusion would be finally reached by Christmas but it is now expected that the baton will be passed on to the Dutch Presidency to complete the dossier in the first half of next year. As the healthcare community waits in anticipation for a final approach to be agreed, a number of contentious issues are still being worked out.

High on the agenda  still is the pre-market scrutiny of devices and the reprocessing of single use devices – both with very direct consequences on patient safety, a piece of the puzzle that may often appear to be overlooked in these overly technical discussions. The Council and Parliament are still at loggerheads over the concrete implementation of the former and one begs to ask the question, at which point will the balance between additional regulatory hurdles and faster access for patients be struck? While the Council may have the right approach by integrating the additional level of scrutiny within the existing process, their desire to restrict this to Class III devices doesn’t have the support of the Parliament, more concerned with taking all the necessary precautions.

The second issue is no less contentious as it wants to address a concerning effect of the economic crisis, the reprocessing of devices that were manufactured for single use. Council is divided and leaning towards national empowerment once again. As a result, the healthcare community is rightly concerned about double standards and even varying degrees of standards between Member States. When a device has been specifically manufactured to be used only once, it is hard to understand why the Parliament is advocating for the reuse of all devices. As the discussions continue, other issues are making their way into the trilogues, for instance the labelling of hazardous substances, which is supported by Member States who once again seem to be taking a pragmatic approach.

The slow and painful process of reaching an agreement has been frustrating for the healthcare community and all eyes lay on the Dutch Presidency to exercise their diplomatic skills with the Parliament to reach an acceptable outcome for patients.

Lavinia Trehane is Senior Consultant in FTI Consulting’s healthcare team.

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