The deadline for compliance with the European Union Medical Device Regulation (EU MDR) is fast approaching, which places its own challenges on companies who are under-staffed for such a large-scale transition. Additionally, 78% of medical device companies (according to recent reports) believe that they do not have the required understanding of new legislation in-house. So, what can medical device companies do at this critical time in the industry? Aside from improving their existing team’s knowledge, we’re seeing more and more organizations partner with consultants who offer expert guidance when travelling the road to MDR compliance.
We recently sat down with Trey Thorsen, as a Concilium approved consultant and former Director of Quality and Regulatory Affairs at HARTMANN USA, he is now supporting medical device companies through some of the grey areas around EU MDR compliance. We discussed some of the challenges he sees coming from this transition and some of the actions to be taken by medical device companies sooner rather than later.
Hi Trey, great to speak with you at what I know is a very busy time! To start off, can you give me a brief overview of your background in medical device’s regulatory affairs?
“I have been working in the medical device industry since 2003. I started out as an analytical chemist in the QC lab. In 2006 I made the move to regulatory affairs and in 2009 I received my Master of Science in Pharmaceutical and Biomedical Regulatory Affairs from the University of Georgia.
I have gained experience in all 3 FDA device classes working with companies such as Femasys (women’s healthcare) Stryker, St. Jude Medical (now Abbott) and HARTMANN USA (wound care). With these companies I have worked on devices from Class 2 transvaginal catheters that evaluate fallopian tube patency, to Class 1 and 2 surgical operating equipment booms and lights, to Class 3 implantable pulse generators with MRI functionality and Class 1 sterile wound care devices. I have now started a medical device regulatory consulting company O’Connell & Myers, LLC.”
What do you see as the biggest challenge facing regulatory departments right now?
"The biggest challenge that faces RA departments today is change. As the device world knows there are new regulations in the EU, there is the new version of ISO 13485:2016, the Medical Device Single Audit Program (MDSAP). There is also talk of the FDA revising 21 CFR 820. So this is a very interesting time to be in regulatory and quality."
How can regulatory teams respond to this proactively?
"I think teams need to start evaluating the status of their QMS and develop a plan that will allow them to jibe and tack during the changing winds of the regulatory field. If you haven’t at least got a draft of a plan that examines the overall impact of the MDR on your company and how your notified body can get you certified, you may have an issue when it comes to selling devices in the EU post 2020. Another thing that companies need to do is inform their entire organization about the changes to the regulations. The RA departments will be swamped and may not be available to support smaller projects."
Where do you see the biggest impact on regulatory teams as a result of MDR?
"This is a good question and it’s a big question. The impact is huge it not only effects device companies but notified bodies as well. Manufacturers need to communicate with their NB to make sure they will still be able to review your devices, so you can maintain your CE mark.
From a premarket side the focus is on the total product life cycle. The Essential Requirements Checklist will be replaced with Safety and Performance Requirements. This new document will require that you include your method of conformity (ex. animal testing, V&V reports etc.) and cross reference your documents. You can no longer just point to your SOP.
Another big thing that will cause waves is labelling. Every device label must be updated with UDI information and the addition of a medical device symbol.
Manufacturers will have to establish control over their Economic Operators (ex. Authorized Reps, distributors and importers). If you use an OEM you need to determine how you will show you have control over the technical documentation. Needless to say, your legal team will be revising your agreements with these suppliers.
In the Postmarket world there is more emphasis on surveillance and vigilance. This info will also be publicly available, and companies are required to trend and report periodically by using Periodic Safety Update Reports (PSUR) that must be kept updated.
There’s a lot of changes to the clinical data requirements too. Companies must evaluate their CERs and make sure they are “state of the art’ and align with the MEDDEV 2.7/1 Rev 4. The MDR is making it harder to use literature and equivalence to prove safety and more focus on powered clinical studies (especially for high risk devices). Companies will also have to have a Post Market Clinical Follow-Up Plan for all devices.
These are just the tip of the iceberg. So companies need to begin to evaluate and prioritize their portfolio and make sure they are staffed with enough qualified people to handle all of these changes."
What do you believe the next big challenge will be for Medical Device companies in years to come?
"I think keeping up with technology will be the biggest challenge. We all know that it feels like every day there’s a new computer or blue screen that will do it smarter and faster than the product we had yesterday. I think that regulators need to begin thinking about how the speed of innovation will impact getting a device to market and how regulations need to evolve so that technology can help save and protect lives."
Clearly, there are a lot of changes to the medical device world right now. Whether it’s looking at regulatory transitions, or simply looking at the incredible technological developments which underpin the industry as a whole. Being able to translate technical points in ways which are understood by everyone is paramount for patients to continue to embrace the developments happening within this ever-changing landscape. This is also the case when regulatory teams are looking to develop their understanding of new legislation which will shape the industry for years to come.
The deadline for EU MDR is fast approaching, and now is the time to take proactive steps to ensure that devices which would improve the lives of patients are not left behind.
Trey Thorsen - President, O'Connell & Myers, LLC