Simplifying IVDR Compliance: Insights from Senior Consultant Emily Malmberg

Emily Malmberg’s passion for medicine and biology led her from academia into the dynamic field of medical devices. As a Senior Consultant at GBA Key2Compliance, she leverages her extensive background to guide companies through the intricacies of the In Vitro Diagnostic Regulation (IVDR).

“Transitioning from academia to the medical device industry allowed me to apply my scientific knowledge directly to healthcare solutions,” Emily reflects. “At GBA Key2Compliance, we make complex regulatory requirements more accessible, enabling our clients to focus on innovation.”

Embracing the Opportunities Within IVDR

The In Vitro Diagnostic Regulation (IVDR) is a major regulatory overhaul designed to improve patient safety, clinical evidence, and performance evaluations for in vitro diagnostic devices. Compared to the previous IVDD, IVDR introduces stricter requirements, including risk-based classification, enhanced clinical evidence, and increased oversight from Notified Bodies.

“While the shift to IVDR introduces more rigorous requirements, it ultimately leads to safer and more effective diagnostic tools,” Emily explains. “We assist our clients in transforming these regulatory challenges into opportunities for excellence.”

Proactive planning is essential. Emily advises companies to initiate their compliance efforts early, turning potential obstacles into strategic advantages.

“The biggest shock for many manufacturers is that they can no longer rely solely on literature reviews,” Emily explains. “They need extensive clinical data, and in many cases, full-scale studies. That’s a massive shift from the previous regulatory environment, but it also ensures safer and more effective diagnostic devices for patients. The level of evidence needed is often a challenge, but a well-constructed performance evaluation will facilitate. A challenge for all parties is the lack of guidance documents regarding IVD and performance studies. Everyone in the field is still learning.”

One key change under IVDR is that many devices have been reclassified into higher-risk categories, requiring companies to generate and maintain significantly more clinical data than before.  And in addition, they need a notified body to oversee their technical documentation. This shift has created new challenges for manufacturers, but those who start early and follow a structured compliance plan will be better positioned for success.

“Early engagement with IVDR compliance not only ensures timely market access but also positions companies as leaders in quality and reliability,” she notes.

Want to learn more about IVDR and what it means for your business? Read more here.

The Role of a MedTech CRO in IVDR Compliance

Navigating IVDR compliance is a complex and evolving process. It’s not just about understanding the regulations but about applying them in a structured and strategic way. From initial evaluations to risk assessments and data-driven decision-making, every step must be carefully executed to ensure both compliance and a smooth path to market. Clinical development, in particular, demands a collaborative approach where manufacturers work closely with experts to generate the right evidence, document findings accurately, and align with regulatory expectations.

“IVDR compliance isn’t something companies should have to tackle alone,” says Emily. “By bringing together specialists across multiple disciplines, we ensure that everything—from performance evaluation to clinical studies and technical documentation—is handled with precision.”

This expertise comes from a multidisciplinary team with backgrounds in regulatory affairs, performance evaluations, clinical operations and quality assurance. Each specialist brings a different perspective, helping to address compliance hurdles efficiently while keeping the broader business goals in focus.

“We don’t believe in one-size-fits-all solutions,” Emily explains. “Instead, we assess the specific needs of every project and leverage our expertise to streamline the compliance process.“.

Guiding Clients Through Seamless Compliance

For many manufacturers, the compliance journey begins with defining the intended purpose of the IVD – a step that is often more complex than expected. The documentation required before even considering a clinical study is substantial, and missing elements can cause costly delays. Emily and her colleagues work closely with clients to establish a structured approach from the start, ensuring that compliance is not just a regulatory obligation but an integrated part of product development.

“You build your documentation from the intended purpose onward,” she explains. “Many clients are surprised by the level of detail needed before clinical studies can begin. By planning ahead, we make the process more manageable and reduce bottlenecks down the line.”

Rather than breaking compliance into isolated tasks, the focus is on strategic planning and alignment with regulatory expectations from day one. This methodical approach streamlines the entire process, making it more efficient and less daunting.

Looking Ahead: Trends in IVDR and Innovation

The integration of artificial intelligence (AI) into medical devices presents exciting possibilities alongside new regulatory considerations.

“AI-driven diagnostics are revolutionizing healthcare,” Emily observes. “Staying abreast of regulatory updates ensures that these innovations meet the highest standards of safety and efficacy.”

Emily encourages companies to view compliance as a catalyst for innovation.

“Embracing regulatory requirements fosters a culture of continuous improvement, leading to products that truly make a difference,” she asserts.

The Value of Expert Partnership

• Strategic guidance from day one – Fewer delays, fewer regulatory issues
• Stronger evidence generation – High-quality clinical & performance data
• Expertise without hiring internally – Cost-effective, scalable support
• Faster, smoother market access – Well-prepared submissions, fewer rejections
• Ongoing compliance support – Stay ahead of regulatory demands

Compliance isn’t just a hurdle – it’s a competitive advantage. With the right MedTech CRO partner, manufacturers turn regulatory challenges into opportunities for growth.

Need expert support with IVDR compliance? Contact our team today to discuss how we can help!