The unique intersection of Advanced Therapy Medicinal Products (ATMPs) and medical devices presents numerous regulatory challenges. As these technologies work more and more in combination (like cell delivery devices or tissue engineering scaffolds), companies must navigate overlapping regulatory frameworks.
With the boundaries between ATMPs and medical devices continue to blur, regulatory strategies must evolve. Companies who develop combination products face the challenge of satisfying both EU’s ATMP Regulation and Medical Device Regulation (MDR) requirements at same time. This dual-pathway approach requires cross-functional expertise and early engagement with regulators to ensure a streamlined path to market.
While Regulation (EC) No 1394/2007 provides some framework for combined ATMPs where medical device is an integral part of the product, many scenarios still fall into regulatory gaps. Although this regulation addresses combined products, it does not provide complete clarity for complex innovations we see today. Even with this regulation in place, manufacturers struggle with classification decisions, conformity assessments, and determining which requirements take precedence.
What is most challenging is the regulatory grey area that exists for many innovative combination products. Current frameworks were not originally designed for these hybrid technologies, resulting in substantial gaps in specific guidance. Manufacturers often find themselves putting together requirements from multiple regulations, with limited examples for their unique products. This regulatory uncertainty can delay development timelines and increase costs as teams navigate unknown territory.
How have you approached classification discussions with notified bodies for borderline products? Which aspects of current regulatory frameworks do you find most inadequate for complex combination products? What regulatory harmonization efforts do you believe would be most beneficial for developers in this space?
At Starodub, we help clients bridge these regulatory gaps by providing expert guidance on classification strategies, regulatory pathways, and compliance with evolving EU requirements. Our experience in regulatory affairs enables us to support developers in aligning with both ATMP and medical device regulations, ensuring a smoother path to market.
If you need expert support navigating the regulatory pathway for your ATMP and Medical Device combination product, contact us via our Contact form.
