A month ago, the trilogue on the medical devices (MD) and in-vitro diagnostics (IVDs) regulation proposals have started.This discussion between the Council of the European Union, European Parliament and European Commission is one of the last steps of the process to land a consolidated text for the regulation.
It’s almost the end of the road yet I can’t help but feel the underlying need to improve how the trilogue process is being organised so far.
In the current three-way trilogue, I am concerned that the discussions on the IVD proposal are being overshadowed by topics on the medical device proposal. This concern is shared not only by the industry alone but also by several member states and officials from both the European Parliament and Commission.
I’ve written in my last two blogposts the actions and consequences we needed to understand about the in-vitro diagnostics and medical devices proposals. While it may seem that these two medical technology sectors have a lot of similarities, it’s also important to note their striking differences. This is simply because, by nature and function, IVDs and medical devices are two different sectors with each having a distinct use, issues and applications.
In reality, unlike other forms of medical technology, IVDs never interact directly with the human body. Their purpose is not to have a direct therapeutic effect, but rather to provide valuable information on a patient’s health status.
The value of IVDs comes from the information they provide. This means that the expertise of the healthcare professional in using an IVD is crucial to ensure the correct decision making for patient treatment and care. This sets IVDs apart from medical devices and pharmaceuticals, and is part of what makes them unique amongst health technologies.
Given this reality, the requirements that will be put in place in the proposal should be feasible and applicable towards the nature of IVDs and medical devices. A text that might sound right for one device doesn’t mean that it makes sense to the other.
And despite similarities in the text, each proposed regulation when implemented will have very different impact for IVDs and medical devices. And the consequences to the sector and to patients will be striking, if the details are not clarified and addressed.
I strongly encourage those involved in the trilogue to ensure that the debate in the IVD and medical device files be treated on its own technical merit and be given adequate time, attention and resources to review the important details.
As I said before, I want this regulation to work – for the industry, institutions, and most importantly for the patients. The end is near and I want everyone involved to carefully consider the process and ensure that the conclusion we get is the conclusion we need.