On a typical day as a PTS employee, you might be a bit dismayed to see your email inbox filling up with dozens of rapid-fire messages from your bosses.
But it was no cause for email-induced anxiety on at least two days last month, as congratulatory messages poured in:

“Great job, team. This is a big deal.”

“Great job and your perseverance paid off!”

“Great news for all of us.”

“It sure is an exciting time to be part of PTS!!”

The causes for all this celebration were that, one, our IVDR team completed the process of self-certifying the CardioChek Plus analyzer allowing us to resume sales in the European Union, and two, we were awarded Mexico’s 2022 tender for lipid panel tests. Both are major accomplishments for us as an organization and are a testament to the grit and determination of PTS employees.

What It Takes to Get IVDR-Certified

In May of 2017, The European Union (EU) announced changes to its Medical Devices Regulation (MDR) and the In Vitro Diagnostic Medical Devices Regulation (IVDR). The new regulations were designed, in part, to require more transparency from manufacturers and to unite EU member countries under a consistent regulatory framework.

In May of 2022, the EU began enforcement of the new regulations which requires manufacturers to have their products certified under IVDR before they can be sold in EU countries.

So, what has this meant for us and our products? Well, for starters, it has meant that our products were placed into new classes which require more rigorous documentation, and in some cases, additional certification by a “notified body” to become certified. (A notified body is a company that has been certified by the EU as a company that can legally certify manufacturers under IVDR.) It has also meant that before we could even begin the process of certifying a product, we had to certify our entire Quality Management System (QMS.)

Does all this sound a bit overwhelming? That’s because it is. Especially when you consider that no member of the IVDR team is solely focused on it as their only project. Each person on the team, which is led by Heidi Strunk, Carolyn Schmitt, Janice Keeney, and Steve Zucker, has been juggling multiple projects while wading through thousands—literally thousands!—of pages of new IVDR requests and clarifications.

Another important component of the project has been navigating the necessary changes to product labeling that are required with each IVDR submission. Latasha Little has led the IVDR labelling efforts for the better part of the last year, working in close collaboration with the Regulatory group to research labeling needs, create labeling drafts, and develop updated standards for creating artwork for vial labels, boxes, and package inserts.

This makes the fact that we were able to hit our deadlines for products in our space and achieve IVDR certification even more remarkable.

Being allowed to sell the CardioChek Plus analyzer in the EU has obvious benefits. But the current IVDR efforts may help us get additional products approved in the EU more quickly. Carolyn Schmitt, Regulatory Affairs Manager, explained:

“We took what learned from the QMS certification and applied it to the CardioChek Plus analyzer certification. Right now, we are working on getting Cholesterol and Lipid Panel through the certification process, and we are applying what we learned from the analyzer certification to those. Each one gets a little bit easier as we learn what EU commission and our notified body needs from us. There really wasn’t a roadmap, since all of this is new. We had to make our own.”

In the future, our IVDR efforts may also give us a future advantage in other markets. Other countries are beginning to request information in formats similar to the IVDR data submissions. The level of detail we have had to provide in our documentation of every aspect of our business—from production to post-market surveillance—and all the things we’ve learned along the way are preparing us to smoothly jump over any regulatory hurdle placed in front of us.

But what it takes to get certified under IVDR is more than an eye for detail and an abundance of patience. It takes people who care, and who work hard to support each other through big challenges like these!

¡Viva PTS! The 2022 Mexico Tender

Each year, our International Sales team submits a proposal for each of Mexico’s government tenders for A1C and Lipid Panel testing. Last year, we lost the A1C tender to a competitor. And, the Lipid Panel tender was abandoned, meaning that it was not awarded to anyone. It was a big disappointment, but it didn’t mean that David Brandt and his team were going to give up on it!

And, as we learned on September 7, that perseverance paid off. We were selected to supply Mexico’s government with Lipid Panel tests for 2022. According to David, this would not have been possible if we had not been in the right position to supply the tests.

“Before we can even bid, we have to complete all of our regulatory processes and make sure our Mexico registrations are current. We have the Quality & Regulatory team to thank for that. Also, the Mexican government had to feel confident enough in our operations to trust that we could deliver the products they needed on time. So, thank you to our production teams for running a world class operation. And, thanks in advance to our Customer Service and Technical Support teams who will be helping our customers in Mexico have the best possible experience with our products.”