It is important that the medical technology sector functions within a healthy ecosystem. Our sector needs an environment that is open, supportive and free from unnecessary bureaucracy in order to innovate and provide patients safe and effective solutions to their condition.
Within the product lifecycle of a medical technology product, we work with patients, doctors, authorities and notified bodies to ensure that the product meets all the essential safety and performance requirements. Each group has a critical role to play, which in turn enables manufacturers to deliver to patients the medical technology products they need.
Notified bodies are the authority-controlled third-party, independent entities responsible for assessing whether a medical technology (device or a medical test) conforms to the relevant legislation in force.
Over the last three years, however, we’ve noticed a significant decrease in the number of notified bodies. Some have been de-designated, had their scope restricted or voluntarily stepped down as a notified body in the field of medical technology. This decrease has meant fewer notified bodies are available to assess new products and renew certificates needed by companies to operate.
At the same time, existing bodies are finding it difficult to find qualified personnel to help with the extra workload.
The current situation with respect to notified bodies threatens the stability of the medical technology ecosystem. Without fully functioning notified bodies, our industry’s capacity to innovate is stifled. More importantly, it risks delaying or blocking patients’ access to needed medical technology.
Because of these limitations, the approval process can take longer, subjecting products to considerable delays.
In a time where product innovation is growing at a fast rate, we need a stable ecosystem of notified bodies that’s able to fulfil their roles and guarantee an efficient and timely service.
And without this stable ecosystem, how can Europe guarantee that patients get access to innovative products and services?
Impact at the heart of MedTech: SMEs
Within the medical technology sector, SMEs are the most vulnerable to this issue. In an industry where SMEs compose 95% of the companies, we need a stable system that will allow SMEs to thrive.
Many SMEs have reported increasing difficulties working with their notified bodies, severely impacting their operations.
I spoke with some SMEs and many of them indicated facing delays of a minimum of 6 months but often much more in certificate renewals, product releases, and product assessment.
“[We expect that] there will be increased costs” according to one of the SME directors I spoke with.
All this can seriously threaten the existence for some SMEs thus leading to a reduction of industrial activity and employment.
This trend is alarming. And if this continues, then our industry risks difficulties in how we function and contribute to the healthcare cycle.
Further challenges from the proposed new regulations
Under the new medical device and in vitro diagnostic regulation proposals, notified bodies will be facing an even more important and challenging role. Once the regulation is approved, it is expected that notified bodies will have more work due to new requirements and processes that they will have to take on board.
The in vitro diagnostic regulation also proposes that most tests will be subjected to assessment, thereby increasing the amount of products that notified bodies will likely review.
With these new regulations, it is clear that notified bodies workload will explode and with less notified bodies capable of doing this work; we risk even further unnecessarily delaying access for patients to needed products and burdening the healthcare industry lifecycle as a whole.
Solutions on the way?
Notified bodies play a critical role in the functioning of the EU medical technology system and as such need to be able to do their jobs properly.
Talks are now in place with authorities, the European Commission and notified bodies on how to ensure that these issues are addressed, especially in light of the foreseen adoption of the new regulations. We need to continue to alert our authorities of this situation.
Should all medical technology products (devices or IVD test) undergo a full revision as if they never existed due to the new regulations? A very large portion of our products has been used daily with great safety and contribution to patient conditions for years. So the answer is probably no.
Hopefully, these solutions can be found quickly.
Let’s not forget that it is patients who are at the forefront of this issue and will be the ones who ultimately are affected by any delay or even the absence of new innovative medical solutions to their situation.