FDA-Like Regulatory System Would Cost Europe $23 Billion

In a recent Eucomed survey, medical device manufacturers in Europe estimated that a rigorous, FDA-like premarket authorization (PMA) system form medical devices would cost more than $23 billion. A significant proportion of the cost would be the result of implementing a unique device identification system and improving labeling and clinical performance data. While passing muster with FDA PMA requirements can be a daunting and expensive challenge for many medtech manufacturers, the FDA regulatory system is world-renowned for its high standards and ability to protect patients. Manufacturers and investors have criticized the system as being overly burdensome. In comparison, the existing European CE Mark system poses fewer regulatory hurdles for manufacturers, allowing a product to be brought to European shores for a lower cost. As a result, in many cases, medical device companies pursue European regulatory approval before U.S. approval. Once a medical device has been vetted in European markets, many manufacturers begin to focus getting the products through the FDA to gain access to one of the largest markets in the world. The EU CE Mark system is widely viewed by industry to be an efficient means of ensuring safety and efficacy of products, the European regulatory pathway has been the subject of criticism for its leniency. Following a massive scandal involving substandard breast implants manufactured by PIP, a French company, many are questioning the safety and efficacy of the CE Mark system. However, implementing a new system could place a significant burden on small businesses."It is crystal clear that our industry is willing and committed to invest in measures that effectively improve the system to ensure patient safety. These measures include for example the introduction of a unique device identification system and improvements in labeling and clinical performance data, which will require a EUR7.5 billion [$10 billion] investment," noted Serge Bernasconi, CEO of Eucomed.