medicaldeviceslegal

Bottlenecks, Brexit and stalling CAMD roll-out

With the summer holidays about to happen and the halfway point of the three year transitional period for the MDR on the horizon, let’s take stock of where we are. If you are a manufacturer and have just started thinking about this MDR or IVDR thing, you are in a bad place. Maybe you have a very limited number of devices that are subject to little change under the MDR or IVDR. In that case, count yourself lucky because you’re a happy minority. You may still have enough time to remedy your devices for MD [...] « Read the rest of this article on medicaldeviceslegal »
medicaldeviceslegal

Bottlenecks, Brexit and stalling CAMD roll-out

With the summer holidays about to happen and the halfway point of the three year transitional period for the MDR on the horizon, let’s take stock of where we are. If you are a manufacturer and have just started thinking about this MDR or IVDR thing, you are in a bad place. Maybe you have a very limited number of devices that are subject to little change under the MDR or IVDR. In that case, count yourself lucky because you’re a happy minority. You may still have enough time to remedy your devices for MD [...] « Read the rest of this article on medicaldeviceslegal »