The European Medical Devices Regulation has introduced new criteria and more stringent requirements for the certification of new products, while imposing restrictions for the certification of “equivalent” devices, especially for substance-based DMs.
During the the XIII session of the 63° AFI Symposium, entitled “Synergies and innovation in healthcare: the role of medical devices”, to draw a preliminary assessment of the advantages and disadvantages of the new legislation and there will be an opportunity to present critical issues that emerged from the analysis of the AFI Study Group, discussing with all the actors involved and stimulating a discussion on possible paths resolutions.
As Paola Minghetti, AFI vice-president, underlines during our interview, the New Regulation on Medical Devices has introduced new requirements that impose challenging aspects for companies: the transaction, therefore, is not simple, requiring the involvement of new professional figures and new skills. Furthermore, there is no doubt that the new rules increase certification costs with prolonged and uncertain times. The Notified Bodies themselves have to face an unclear situation, where the continuous discussion between the parties is revealed as one of the necessary solutions.
We must take into account, as Paola Minghetti again reminds us, that the world of medical devices is very complex and has characteristics that make it very different from other types of production.
This scenario can create a loss of innovation and development for this category of products and, consequently, an impoverishment of the therapeutic proposal for the patient.
