Emmett Devereux

Emmett Devereux is Director of Government and Regulatory Affairs for Cook Medical in Europe, Middle East and Africa.  Emmett is focused on developing and implementing strategies and policies that raise awareness of patient access to medical technology. Fostering a business environment that is supportive of innovation in healthcare and the advancement of patient care is a core focus for Emmett.

The development and harmonisation of Global, Middle Eastern, European and National legislation in relation to the medical device industry is a priority for Emmett and the wider Government and Regulatory Affairs team.

Emmett joined Cook Medical in 2001 and was an integral part of the leadership team in Limerick. During his time with Cook the company grew to 900 employees and established an extensive range of shared services, including regulatory and quality teams that support the business across EMEA.  Prior to joining Cook, Emmett held positions at Bausch and Lomb, Summit Technologies and Johnson and Johnson.

Emmett represents Cook Medical on the Medtech Europe Regulatory Affairs Committee and the Public Affairs Committee. He is an active member of the Irish Medical Device Association and is past chair of their Regulatory Affairs Committee. Emmett is also an active member of the UK Trade Association and is an active member on both its Regulatory and Public policy committee. He is a past Board member of MECOMED which is the Medtech Association for the Middle East and North Africa. He currently acts as an industry observer on the International Medical Device Regulators Forum (IMDRF) working group and is an advocate for the for global regulatory harmonisation in the field of Medical Device Regulation.

Emmett also has responsibility for the oversight and approach taken by Cook on a number of key EU Trade associations across many of the member states in the EU.

He is a past member of GHTF Study group 3; National Standards Association of Ireland (NSAI); and, of TC210 on the revision to ISO13485.

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...