We’re right in the middle of a year of change in the EU. Europe has begun voting and EU politics may look quite different as a result. New things and new faces may be on the horizon but that doesn’t mean that work has stopped on a file of great importance to the Union’s more than 400 million citizens: the revision of the EU medical devices and in vitro diagnostics directives.
Indeed, the EU Council, made up of health ministries from the EU’s 28 member states are hard at work tackling that task. On the diagnostics side, you can read my most recent dispatch on Clinical Evidence “for In Vitro Diagnostics” here.
Eucomed, for its part, reiterated its points a few weeks back in an updated position paper.
Today, I’d like to elaborate some more on the topic of clinical requirements, this time from the medical devices perspective. This issue is of such a critical nature we simply must get it right to make sure the final text of the Medical Device Regulations works for patients and innovation.
Before I go into the topic I wanted to briefly touch on the timing aspects of the regulatory process. I sometimes pick up messages that the process in the Council is moving too slow and that this would be in the interest of industry. Let me be crystal clear that this is not the case. We are not looking to slow or speed up the process. What industry wants is the best possible regulatory framework that works for patients, regulators and industry. And the faster we have a good regulatory framework the better. And I am saying again: good, fair and balanced regulatory framework It’s now up to the trialogue partners to decide how long the process will take.
Catering to diversity
Testing medical devices before they hit the market is an absolute must – device makers have been required to do this and they always should be required to do this. But the way a device is tested should be tailored to the device itself.
In a diverse sector of over 100,000 different devices, you just can’t expect to find a “golden formula” that demonstrates the safety and effectiveness of devices whose origins, uses and engineering are worlds apart – like, for example a pacemaker and a prosthetic leg. One keeps your heart beating while the other keeps you mobile. If a prosthetic leg could pump blood through your circulatory system, you could make a case for testing them in the same way. But of course, it can’t.
What won’t work is a “one-size-fits-all approach”, which is reflected in the European Parliament’s position and would require randomised control trials (RCTs) for every iteration of every device headed to the market. So we need a solution.
A tale of two camps
Among our EU stakeholders, two camps seem to have formed: one camp that understands that a one-size-fits-all approach to clinical trials is not suitable to the diverse medtech sector and a second camp still convinced that this route is the only way to go.
We firmly believe that a one-size-fits-all approach is not appropriate for medical devices. Running a full clinical trial for each and every iteration of a product would effectively bring the innovation cycle to a halt and would in many cases be considered impractical, unethical and scientifically unsound.
Suppose for example that you’d like to insert a longer-lasting battery into version 2.0 of your pacemaker. The device itself is the same, but the battery is better. Under the one-size-fits-all approach, you’d have to run a full clinical trial on the whole product, slowing down the innovation cycle and wasting precious time and resources.
We sense a concern in the latter camp that anything other than a one-size-fits-all approach will allow for loopholes that could compromise device effectiveness and safety.
I want to make clear that the medical device industry also wants to close any and all possible loopholes—not merely “wallpapered over” them only to have them resurface later on.
We want to create not just a level playing field, but a fit-for-purpose playing field that allows only safe devices on the market. And to make that happen, we need to look closely at how we define clinical evaluation in the new Regulation.
A properly laid out and delineated text on clinical evaluation could be the key to a solid set of clinical requirements. To get the system right, we need clarity, transparency and consistency. Clinical Evaluation requirements should:
- be fit-for-purpose to the realities of medical technology;
- set clear and appropriate requirements for manufacturers; and
- be subject to rigorous audit by notified bodies, with the basis for approval being transparent to all.
If we can achieve these three criteria, all possible loopholes will be closed.
There’s no doubt that there’s room for improvement when it comes to clinical requirements and the device industry wholeheartedly welcomes this change. But we need to be careful not to put a system in place that we’ll regret later – a system that has us running lengthy clinical trials to test batteries that clearly work, while patients and doctors are left to wait.