In my view, a good legislation needs to be clear and feasible. A regulation that breeds complexity doesn’t help anyone. The medical device discussions are coming to an end with the current trilogue discussion between the European Council, Parliament and Commission. While we welcome the general direction of this regulation, I worry about the unnecessary complexity that remains in some areas. As I said in my IVD regulation blogpost, we want this regulation to happen. However, it is key for all stakeholders to understand that the new regulation must be clear, feasible and applicable.
The medical device industry is the backbone of our healthcare systems. Patients are the ones who benefit from these technologies. I want that this new regulation guarantee a combined vision that advocates for people’s rights to live a healthy life.
And with the trilogue just starting, I invite our policymakers to be vigilant and attentive in evaluating the impact of the regulation. There are points in the medical device file that need to be reviewed, and we have highlighted them all in our medical device regulation position paper. And for my blogpost this month, I have decided to summarize a few key points to make my case:
If scrutiny is added, then it needs to be workable
The medical device industry undergoes a strict control process to ensure that the products we release are of high quality and are safe for patients. These quality controls are very important for all stakeholders, particularly for patients and also for us within the industry.
Within the existing rules, there are officially approved entities called notified bodies that review and implement this process. We support strengthening the capacity of these notified bodies across Europe to provide an improved standard of checks.
However, placing a duplicative system to further check (scrutinize) a product after it’s been reviewed – as the proposal seems to suggest – creates redundancies and delays that have no safety gains for patients.
Any ‘scrutiny’ process needs to be clear and predictable. An unpredictable regulatory process hampers innovation and investment in developing new medical solutions.
Clinical evidence requirements have to be scientifically sound
Data and resources are used to develop our products. Clinical evidence is required to ensure that medical devices provide benefit to patients. However, the council’s regulation proposal in meeting this requirement tweaks the definition of what are considered valid and reliable data sources. These changes in definition proposed, create unintended consequences that ignore decades of scientifically valid data.
For example, there is no point in testing a fact that already has been proven in multiple research and trials. You won’t test a wheel if it rolls right? We all know it rolls and no one will push to test it again and again every time a new car model is developed.
Quality standards should apply equally to all
We ensure that our products retain high safety standards when it goes to patients. We know that there are some medical devices developed and produced to be used once (classified as ‘single-use’ medical devices) that end up being reprocessed so that they can be used again. While we can ensure that products meet the quality standards once it leaves the manufacturer, it is a different story once a product has been reprocessed by a third party without specific expertise for such product.
Reprocessing is done by different bodies such as hospitals and professional reprocessors. In the current proposal, both will have different rules and standards from the original producer to comply with. This lack of harmonized standards makes it difficult to guarantee the reprocessed product’s quality and safety.
We want that everyone follow a harmonized level of quality across the EU. Allowing different quality standards for hospitals and reprocessors create risks that put varying standards of safety and quality for patients. Quality and safety should be safeguarded with a clear indicator that a product has been reprocessed. This proposal as it is now makes it difficult to guarantee patient protection. Shouldn’t patients know and give their consent when reprocessed medical devices are going to be used?
The implementation of the new regulation could create temporary shortage and even elimination of critical medical devices and diagnostic tests.
Currently, hundreds of thousands of medical devices and diagnostic tests are being used every day. Over time, they have proved their safety and medical benefits for patients. If we go by the newly proposed regulations all of these hundreds of thousands of medical devices and diagnostic test will have to be reevaluated despite their proven safety and usefulness. The current regulatory structures cannot handle such enormous influx of assessments and industry cannot generate all the required data, even within the possible 3 to 5 years’ time given for the transition.
We urged Parliament, Council and Commission to imagine, propose and select a process which will avoid creating temporary shortage and even the elimination of critical medical devices and diagnostic test. Patients could seriously be put at risk here. Many of the devices and diagnostic tests on the market save lives, are critical and are unique!
The final countdown to a single text is here and we need to make it work
The MDD revision has the makings of a good regulation, but there are more considerations to be done to make it work. There are still complications that need to be straightened out. And what I hope for, is that the policy makers who will be negotiating this, do not only look for a ‘political agreement’ but take the opportunity to create a new regulation which protects patients, stimulate innovation and is practical, implementable and pragmatic.
