Software MEDDEV updated

The Commission issued an updated version of the MEDDEV 2.1/6 regarding standalone software on 15 July. After all the rumors around the difficult discussions surrounding the revision process I was very curious about the changes finally implemented. Unfortunately these changes turned out to be very limited and in my view do not change the scope of the document or even bring anything new. Essentially what happened is that the Commission added some definitions and slightly amended the flow chart for qualificati [...] « Read the rest of this article on medicaldeviceslegal »