Oct 2, 2019

“Navigate your way through the regulatory grey.”

That was the tagline for the 2019 Regulatory Affairs Professionals Society (RAPS) Convergence meeting in Philadelphia this September. As a first-time attendee of RAPS convergence, I could relate. However, for me, and I think for many of the other RAPS attendees, it was like drinking from a fire hose while also trying to navigate through the grey.

MDR, IVDR concerns

Even for seasoned regulatory affairs professionals, the pace of change and lack of clarity of much of the worldwide regulatory information can be overwhelming. The European Union’s Medical Device Regulation (MDR) and In-vitro Diagnostic Regulation (IVDR) were hot topics during the meeting, as was frustration with the lack of guidance from the EU on how to address those regulations. And an even greater concern was whether or not the few EU MDR Notified Bodies that are or will be approved will have the bandwidth to certify medical device products by the EU’s deadlines.

Maintaining multiple medical device registrations

It’s a scary world for a regulatory affairs professionals. One of their key goals is to facilitate innovation and help get products to market as quickly as possible so that patients and caregivers can take advantage of their clinical benefits–and in many cases experience significant performance and safety gains over existing technologies. However, this can’t be done without complying with the daunting number of regulatory expectations from around the world.

For example, I recently had a conversation with a medical device company executive who has 300 different products commercialized in 100 different countries. Just simply keeping track of which regulatory registrations the products had and how the registrations were affected by a seemingly regular stream of regulatory changes was a huge challenge for his company. Other challenge we heard about at the RAPS Convergence meeting included managing Unique Device Identifier (UDI) requirements and implementation tools (like barcoding) across different countries; anticipating how the likely exponential growth of Artificial Intelligence and Software as a Medical Device (SaMD) will be regulated; and understanding regulators’ heightened expectations for use of clinical data to validate premarket and postmarket performance of devices and systems.

Spotlight on Clinical Evaluation Report (CER) reviews

The RAPS Convergence meeting was promoted as being a valuable way to help regulatory affairs professionals navigate the grey. It provided an excellent opportunity to network and learn from peers. The educational sessions were extremely useful and were rich in content. I had the pleasure to attend a session on How to Review and Compile the Clinical Data in a Clinical Evaluation Report (CER) that included presentations by my Emergo by UL colleagues. Evangeline Loh and Heather Crawford. Loh was chair of the session; Loh and Crawford provided an extensive amount of practical information and advice on designing CER literature search strategies, assessing the quality of evidence in the literature, and confirming that clinical data identified from searches actually matches a product’s clinical claims.

Rolling out RAMS 2.0

The conference exhibit hall was aptly named the Solution Center. Emergo by UL ran two separate booths.

One was used to promote Emergo’s established consulting business lines for in-country representation, quality management systems, regulatory compliance, human factors research and design, and cybersecurity consulting services.

The second booth promoted the launch of Emergo’s new Regulatory Affairs Management Suite (RAMS 2.0). RAMS is a platform of digital products to improve, simplify, and automate regulatory affairs and quality assurance activities for medical device manufacturers.

The RAPS exhibit hall was very active throughout the Convergence meeting. My Emergo by UL colleagues and I welcomed a steady stream of visitors at both booths. Just like with the Convergence meeting tagline, a common theme from our booth visitors was that they were looking for guidance to help wade through the large and ever-growing regulatory landscape, and navigate through (and comply with) the grey as efficiently and effectively as possible. No easy task, but with the right and knowledgeable support it can be done.

James Keller is Business Development Director at Emergo by UL.

Related medical device RA/QA resources from Emergo by UL:

  • Worldwide medical device market access consulting
  • Whitepaper: Understanding Europe’s Medical Devices Regulation (MDR)
  • Whitepaper: ISO 13485:2016 and risk-based approaches