Insurance Europe supports the aim of the European Commission (EC) to create conditions for safe, effective and innovative medical devices and in vitro diagnostic medical devices and it fully embraces the objective of ensuring a high level of health protection for citizens. However, Insurance Europe is seriously concerned about the European Parliament’s Environment,
Public Health and Food Safety (ENVI) Committee’s suggested amendments introducing compulsory liability insurance for medical device manufacturers into the EC’s proposals for Regulations on medical devices and on in-vitro diagnostic devices. Such EU-wide compulsory insurance would not, in fact, minimise the potential harm caused to consumers by these devices.
Insurance Europe would like to draw policymakers’ attention to the negative effects that the introduction of EU-wide compulsory liability insurance could have for manufacturers of medical devices and for citizens.