In a significant move to promote transparency and fairness in the medical device market, the European Commission has released a comprehensive list of notified bodies along with their published fees for conformity assessments. This initiative is expected to bring much-needed clarity to the certification process, ensuring that manufacturers, particularly small and medium-sized enterprises (SMEs), can navigate the regulatory landscape with greater ease and predictability.
Before this initiative, the fees charged by notified bodies for conformity assessments were not uniformly disclosed, leading to significant variability in costs across different bodies. This lack of transparency created challenges for medical device manufacturers, particularly for SMEs with limited resources, who often faced unpredictable and potentially prohibitive costs. The variability in fees also raised concerns about the consistency and fairness of the certification process. By publishing the fees, the European Commission aims to address these challenges head-on, promoting a more transparent and competitive market environment.
For medical device manufacturers, especially those in the SME sector, this development is a game-changer. The publication of fees allows companies to compare costs more effectively and plan their budgets with greater accuracy. This transparency can reduce the financial uncertainty that has previously been a barrier for smaller companies looking to innovate and bring new medical technologies to the market. We urge all manufacturers to consider this published price list when looking for a suitable notified body.
The list of published fees can be accessed using the following link
