Medical devices in Europe, all but drugs: time to radically change their regulation?

Medical devices represent a vast category of products that fuel a growing turnover of thousands of small- and medium-sized companies in Europe. After many years of debate, a very analytical and complex new European medical device regulation (MDR) has been approved, but its application is still ongoing. The new European MDR classifies medical devices in four classes by potential risk of harms. The main purpose of this classification by risk is to address new medical devices to the assessment procedure for approval, which falls under the national remit of each member state. According to this decentralized model, manufacturers can choose the countries where to approve their devices. National competent authorities have historically devolved approval of high-risk medical devices to the Notified Bodies (NBs). NBs (mainly private organizations) charge fees to manufacturers in order to assess the safety and performance conformity of high-risk medical devices before their market approval. The new MDR also foresees that an independent advice on the clinical evaluations performed by NBs for certain high-risk medical devices may be required to the Expert Panels (EPs), which are funded by the European Commission. Despite the high expectations raised by the new MDR, the European regulation still suffers major weaknesses and needs a radical change. Instead of the present decentralized and fragmented system populated by too many organizations, a European regulatory agency should govern medical devices approval through a centralized process such as that for pharmaceuticals. Then, national competent authorities should purchase medical devices by combining competitive tendering and reference pricing in order to constrain health expenditures.