And this is a proposal, there were previous unapproved proposals, and this one has to pass the Council and the Parliament. I will not enter into the details.
It was supposed to increase safety and efficacy, but the main problem remains with who has to enforce them. Notified bodies, a subcontracting regulatory firms network, with vested interests with industry can't claim independence. And specifically, the methods for evaluate the analytical validity, clinical validity and utility is uncertain. No regulator will confirm us that the cut-off values of diagnostic tests are set according to the best evidence and greatest benefit. In US, FDA is the responsible.
In summary, a new missed opportunity for european citizens. A greater risk and uncertain effectiveness in diagnostic tests and medical devices.
PS. The latest known example of the impact of wrong regulation is this one. Those affected can't read this blog, they are blind.
Josep Moscardó
