Navarra Health Cluster and its member entity Asphalion launched a new training cycle titled “Regulatory Challenges in Pharmaceutical and Healthcare Innovation” on Tuesday 1 April, with a first session focused on the regulatory hurdles involved in innovation for medical devices, covering procedures in both Europe and the United States.
The session, led by Talyta Carteano, Medical Device Director at Asphalion, covered the classification and certification of medical devices, the role of regulatory bodies such as the FDA and Notified Bodies, and the importance of early regulatory planning in product development.
The regulation of medical devices is a key aspect of developing and commercialising innovative products. Talyta Carteano examined the differences between the regulatory systems in Europe and the US, noting that following the 2017 legislative changes, it is currently faster to bring products to the US market than to the European one — although the current situation in the US brings some uncertainty regarding the new timelines and costs associated with the FDA.
Key topics addressed included risk-based classification of medical devices, the roles of Notified Bodies in Europe and the FDA in the US, and the challenges companies face when certifying innovative products. The importance of considering regulation from the outset of product development, planning certification in advance, and having robust clinical evidence was also strongly emphasised to ensure success in the market.
The certification process can be lengthy and costly, particularly in Europe, where the limited availability of Notified Bodies remains a challenge. In contrast, the FDA offers more transparency and approval routes such as 510(k), De Novo, or PMA, which may facilitate product approval — though each comes with its own risks.
In short, a well-defined regulatory strategy is essential for medical device companies to innovate and thrive in an increasingly demanding environment.
