December 30, 2016
Notified bodies under pressure
After our recent posts on the proposed Medical Device Regulation (MDR) and MEDDEV 2.7/1 rev. 4, it is interesting to shift our perspective, aiming to get a sense of the potential impact of the new regulatory framework for the medical device industry and more specific to the role of the Notified Bodies. Many of you will probably acknowledge that the existing regulatory framework deserved its credits, but we cannot close our eyes for the recent scandals and subsequent criticism, in particular after the metal-on-metal scandal. It is not surprising that the new MDR steers towards a more stringent and more defined role for Notified Bodies, thereby aiming to increase their control over the certification of medical devices.
To get a good sense of the current situation of the Notified Bodies, we have to take a step aside and go back to the period just after the PIP scandal. In response to this scandal, Member States and Commission Experts (following the Commission implementing regulation (eu) no 920/2013) performed the so-called joint assessments. This meant that instead of only the ‘local’ Competent Authority doing the assessment of ‘their own’ Notified Bodies, other Competent Authorities were invited to join these assessments and to provide their – potentially different – opinions.
The outcome of these assessments revealed weaknesses at several Notified Bodies, eventually leading to restrictions of their scope and inability to take on new clients. The impact of the assessments may even better be illustrated by the fact that some Notified Bodies voluntarily decided to take the gracious approach and end their activities for medical devices, not awaiting the outcome of the joint assessment. By now, the number of Notified Bodies has already decreased from 72 to 54 and we would not be surprised if this number decreases even more. It’s simple math to conclude that a reduction of the number of Notified Bodies able or willing to assess medical devices, leads to an increase of work for the remaining Notified Bodies involved in the medical device industry.
Already a year ago the Notified Bodies published their position paper concerning their ‘future’ workload, a clear self-reflective letter. The message of this letter should make us realize that although the new regulations seem to be a step forward towards a more uniform interpretation of the regulatory landscape, it will have a serious impact on the Notified Bodies. It is therefore essential to keep an eye on their reaction. One should definitely ask the question: will they be able to cope with the increased pressure of being in the spotlights?
We recently saw a Notified Body that did not renew a CE mark after the manufacturer included ‘only’ 238 subjects of the required 250 in their post-market clinical follow-up study. Unfortunately, this is not an example on its own, it rather should be seen as an illustration of the current situation. These symptoms of Notified Bodies struggling with the amount of work and the pressure of the joint assessments should be taken seriously. It looks like they are caught by the quality versus quantity trade-off. From the one side, their deliverables and standards are placed under a magnifying glass, whereas the number of requests increases.
Bearing this in mind, one could argue whether more stringent requirements for the Notified Bodies immediately lead to a high level of protection of human health in the medical device industry. Having the position paper in the back of our minds, the new set of requirements could become an ironic party crasher. In our current framework, devices will be granted access to the market when they actually do what they intended to do, with a key role for the Notified Bodies. However, if the Notified Bodies are unable to deliver what they are actually required to do, the system does not lead to the desired result. Is it realistic in this early stage to question whether the MDR is raising the bar too high for the Notified Bodies? And subsequently could that lead to stagnation of innovation in the medical devices industry?
Taking a small leap in thoughts;
The Notified Bodies may directly perceive an enormous increase in workload and pressure, however the new MDR requires the entire medical device industry to invest in safety and quality, not only in the pre-market phase but during the entire life-cycle of medical devices. Ultimately, the MDR will provide a framework very well suited for the current spirit of age, though we should not panic or freeze because the MDR requires us to change the procedures we are familiar with. Getting used to the new regulation and its requirements will be a habituation process, but apparently that is the price to pay for the recent scandals. Ensure you are prepared; Start sooner finish faster
By Alwin van den Broek