The pandemic has changed many aspects of our lives. This is no different for those of us in the medtech space where we were pushed to rethink how we work. In the process, we learned how to find robust alternatives to important processes such as physical audits. These changes also revealed the need for greater harmonisation at a global level to overcome fragmentation between regulators.
In my experience, global regulatory agencies responded positively to the challenges posed by COVID-19. Their willingness to engage with the industry was evident and the use of such things of Emergency Use Authorizations helped reduce the roadblocks to getting much-needed devices to patients.
It must be also said, however, that the pandemic exposed some of the weaknesses of the various global regulatory agencies. It laid bare the fact that the various regulators aren’t as well aligned globally as they probably should be. The pandemic highlighted the need for more agility, speed, change management, and urgency—while never compromising on safety—in our current regulatory agencies.
Harmonisation of remote audits
The pandemic also showed that the pace at which the various regulators are driving harmonisation, though organisations such as the International Medical Device Regulators Forum (IMDRF), is simply not speedy enough. The pandemic coincided with the ten-year anniversary of the IMDRF, and the delivery of harmonisation projects has fallen behind what the global patient population requires.
I have seen many examples that highlight this lack of progress on harmonisation, but let’s focus on remote audits. As you may know, a remote audit is an audit performed off-site using information and communication technology. It mirrors all the activities that are carried out during an on-site inspection. In simple terms, it is a robust alternative to a physical audit.
My experience with remote audits has demonstrated to me that they offer an adequate level of safety with no compromise to the overall reliability of assessments. They also bring reduced environmental footprint, increasing speed, and faster execution of required inspections.
Addressing fragmentation together
During COVID-19, the need for remote audits became even greater. Travel restrictions were implemented globally, and the various lockdowns meant that it was extremely difficult, if not impossible, to schedule on-site inspections. This all came at a time when our industry was tasked with ramping up production to meet the needs of the global patient population during a pandemic.
In my opinion, the overall response from global regulators was fragmented, so when steps were taken by regulators, the lack of a global approach meant that remote audits were not implemented in an effective manner.
The US FDA was positive and has adopted various measures that include the recent launch of a pilot programme. The EU responded in January of 2021 with a system that pushed the authorisation and approval of a remote inspection down to the Member State level. This has only led to fragmentation; in Europe, we now have to deal with 27 different competent authority interpretations.
Our experience with remote audits highlighted the fact that even between the major regulatory bodies, there was not a cohesive and global approach. This, of course, led to delays and confusion for the industry and, ultimately, made it more difficult to deliver a timely ramp-up in production and authorisations with the ongoing headache of arranging on-site inspections.
The bigger message here, however, is not just about remote audits. The COVID-19 pandemic has taught us to behave and manage our businesses in new ways. It has shown the need to work together to solve problems and to find speedy and safe solutions.
There is so much that we can learn and will learn from this pandemic, while there are also things we must change. The concept of a remote audit is a good one, but the challenge for all of us is to ensure that we push ahead with the global implementation of a common approach across the global regulators.
The Medical Device Single Audit Program (MDSAP) is an excellent example of a good regulatory tool. However, we need to work on systems such as the single product review programme and the global label requirements, to name two, as well as the recognition of key elements of each other’s regulatory systems.
By working together, the medtech industry and global regulators can build the global regulatory system that patients will need as we look to exit this pandemic.
