11 August 2020 - We sat down to with R&Q's Ruthanne Vendy, RAC to talk about her experience as a contributing author to the Regulatory Affairs Professionals Society’s (RAPS) Fundamentals of EU Regulatory Affairs, Ninth Edition.

Ruthanne Vendy, RACRuthanne Vendy, RAC, a Senior Principal Specialist at R&Q, was selected to be a contributing author to the Regulatory Affairs Professionals Society’s (RAPS) Fundamentals of EU Regulatory Affairs, Ninth Edition, which was recently updated to cover the upcoming implementation of the European Union’s new Medical Devices Regulation (EU MDR) and In Vitro Diagnostics Regulation (EU IVDR), and the subsequent impact for manufacturers, Notified Bodies, competent authorities, and other stakeholders.

In her day job at R&Q, Ruthanne is a member of R&Q’s EU MDR Leadership Team and has spent the past three years supporting clients with EU MDR guidance, interpretation, gap assessments and technical documentation remediations, in preparation for submissions to Notified Bodies. We sat down with Ruthanne to learn more about her experience as a contributing author for a RAPS publication and ask for any advice she has for anyone interested in the EU Regulatory affairs topic. Here is what she had to say:

How did you get selected to co-author this chapter for RAPS?

R&Q had a booth at the RAPS Regulatory Convergence Conference in Philadelphia, and I was walking around on the exhibit floor. I noticed that RAPS had a booth with an area to sign-up for volunteer opportunities, including opportunities to write for them. They had a list of different categories and areas of expertise and I put my name next to areas I thought I could offer value based on my work experience and past speaking engagements. Subsequently, the RAPS team reached out to me to participate in the updated edition of the EU MDR fundamentals book.

>> Visit R&Q at Virtual Booth #206 on 13-16 September during RAPS Regulatory Convergence 2020

What are some examples of the updates that were made in the ninth edition of the RAPS Fundamentals of EU Regulatory Affairs?

The chapter I worked on is primarily related to the legislation itself focusing on medical device classifications, and there are a lot of changes! The amendments we made were focused on representing the changes from the European Union Medical Device Directive (MDD) to the Medical Device Regulation (MDR), since the last version of this book was MDD-focused and this version of the book is more MDR-focused.

The goal of the chapter I co-authored is to help people understand what the new classification rules are under MDR and what has changed in medical device classification. For example, we added a section about products that are now classified as medical devices under the new regulation, but they are products that do not have a medical purpose. One example of this is transdermal implants that are used for aesthetic purposes, such as metal horns or spikes, because they now need to have specific quality standards during production and evaluate risks in the same manner as would be done for medical implants.

What experiences did you lean on for inspiration while co-writing the chapter?

I had a lot of familiarity with the topic in this chapter because I have spent the last three years solely dedicated to EU MDR work. Luckily, I found writing the chapter to move smoothly and easily because I am doing it all the time. I have done several classification assessments for a variety of device classes, spanning from instruments (Class I reusable), Class IIa, and both Class IIb and Class III implantables.

For each dossier that requires remediation, it is critical to do a classification assessment which means looking at the products that fall under that dossier which may include a mixture of products. This process also includes examining pertinent variables and walking through a decision tree for each product or family of products.

How is this book helpful to regulatory professionals? When should I think to pull it out as a reference?

I have always liked the RAPS Fundamentals Series for myself. When I studied for the Regulatory Affairs Certification (RAC) exam, there were so many study materials that it was very easy to get overwhelmed with the plethora of test prep materials that are available to buy, from flashcards to guides. I primarily used the RAPS Fundamentals book because it is a very comprehensive guide, particularly for people new to the field.

For people new to the field, it is very tough to decipher what is the latest information, or if a guidance is superseded by something else that did not show up in the search. This can be misleading and confusing to someone new to the field and unaware of the latest changes. By using the RAPS Fundamentals book, I felt more confident that I had a reputable starting point that would point me in the right direction for the most up-to-date information.

This book is also useful for more seasoned regulatory professionals that may not have time to sift through blogs and newsletters daily; this serves as a comprehensive place of reference to find out what has changed.

What was it like to have the opportunity to work with other Regulatory subject matter experts at RAPS?

Although my experience with this chapter was limited to my editor and co-author, we got along great from the get-go and it was a good collaboration experience – we just clicked! I was very confident with my co-author because there were certain parts in the writing process where she took the lead while I would focus on other parts that I was more familiar with, and in the end, we agreed on all of the content. Overall, writing this chapter with the team was a very positive experience that I enjoyed and learned a lot from.

What are some lessons learned that you are taking from the experience?

I have always liked to write and consider it a forte of mine and because it was such a positive experience, I would be very encouraged to do it again should RAPS have another opportunity to do so. The experience made me realize that I would like to explore other volunteer opportunities because I like to know that I have contributed to something that will help other people.

For many of us, when these types of opportunities come up, we wonder if we have the time for it, but I found that it is worth taking the time to do it. I am very busy with clients, so I was not certain I could take on the extra work, but it was worth finding the time for at the end.

Going to RAPS Virtual Regulatory Convergence 2020? Visit R&Q at booth #206!
Also, be sure to join our session on Wednesday, 16 September, 2020 from 10:35 AM – 11:30 AM EDT where we're bringing an expert panel together to talk about "Postmarket Surveillance Requirements of the EU MDR: Implementation Challenges and Solutions". Learn more about this can't-miss panel here.

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