When the European Parliament finalised their amendments for the Proposal for a Regulation on in vitro diagnostic medical devices in October 2013, they set the scene for a process that has continued through several Council Presidencies. The continued discussions are a reflection of the complexity of the file and the need for careful consideration of the technical aspects of the text, which should lead to the creation of a positive environment for innovation, safety and patient access across Europe.
Thoughts from the industry
The in vitro diagnostics industry welcomes the revision and its intention to strengthen the current approval system for in vitro diagnostics, but highlights that this presents a need for legislation that is appropriate and fit-for-purpose, clearly taking into account the specificities of IVDs. In the new text, decision-makers should acknowledge that IVDs are non-invasive tests that never interact with patients, instead relying on biological samples to provide information that is subsequently used for diagnosis, screening, assessing predisposition and monitoring. The risk they pose to patients is linked to the accuracy of this information and how it is used, not to the devices themselves. This is a marked distinguishing factor when it comes to legislative considerations and clearly separates IVDs from other medical devices, pharmaceuticals or other therapies. It also raises different considerations for the revision itself, including on topics such as the transition period, clinical evidence, post-market follow-up and transparency.
The scope of the revision is widespread and will revolutionise the IVD regulatory landscape in Europe with new responsibilities arising for manufacturers, importers, notified bodies, competent authorities, reference laboratories and the European Commission. Considering all of the anticipated changes and building up of expertise that will be necessary, alongside the number of products that will need to be ‘classified upwards’ within the new, risk-based classification system, EDMA strongly supports the European Commission’s proposal of a five-year transition period for full implementation. By taking gradual steps toward this realistic goal, Europe can avoid a situation that was recently faced by Australia, which after implementing a very similar legislation had to extend the transition period twice as the requirements could simply not be satisfied adequately and safely in anything less than five years.
Clinical Evidence anyone?
For example, the provisions for the gathering of clinical evidence indicated in the European Commission text are much more comprehensive currently required by legislation. The new requirements for clinical evidence, will require significant time and resources both from industry and regulators to properly implement. The proposal thus recognises that IVDs are tested on biobank samples collected from patients at an earlier time, meaning that they do not provide patient management decisions and consequently do not pose any direct effect through the data generation process. In such a way, the Commission guarantees safety and avoids the involvement of patients in any unnecessary studies, also adhering to the Global Harmonisation Task Force (GHTF) best practice on the presentation of clinical evidence.
Yet even once IVDs are in use on patient samples and guiding clinical decisions, IVDs still distinguish themselves from other medical devices in that they are reflective of a patient’s health at a specific point in time. This implies that any future variations in a patient’s health are indicative of changes in a person’s condition rather than inconsistency in terms of testing. The nuance is critical when considering post-market surveillance of IVDs as the long-term effect and continual assessment cannot be carried out in the same manner as it would be for a therapy. If a patient has strep throat today, they probably won’t in two weeks’ time, which is not related to test performance. Without acknowledging this in the Commission text, the surveillance becomes nonsensical for IVDs.
Making the distinction
It is such issues that arise for IVDs – which may not appear for medical devices or pharmaceuticals – that will make the entire difference in the future regulatory framework. If specificities of IVDs are neglected, the result will be unsustainable and lead to stalemates as IVDs simply cannot technically provide the same type of evidence or be monitored through the same methods. In fact, even when considering the transparency of data, intellectual property protection also has to be looked upon from a slightly different perspective. Upon the completion of a study, the generated data becomes public and indirectly permits any competitor to seek immediate benefit. This is particularly true as patent protection for a specific biomarker or gene sequence cannot be obtained. The in vitro diagnostics industry supports transparency, but belives that it must be balanced with the need for data protection so as to drive innovation. It is this innovation that brings better, faster and more accurate testing to patients.
The discussions on the revision of the IVD legislation continue, decision-makers should bear in mind that IVDs are not simply another medical device and there is a reason a separate regulatory framework was chosen – IVDs and medical devices have a different relationship to the patient. This relationship needs to be specifically reflected in many, if not most, of the critical control and follow-up processes. Without this, patient access and innovation in Europe will not move forward, something Europe can simply not afford.
-Jesus Rueda Rodriguez, Director