EBME Forums Forums Management Medical Equipment Management Inhaled gas humidification on neonatal transport

Not at all!
The MDD directive is sound guidance. It clearly looks not just at medical devices in isolation, but when they become part of a medical system.
It’s not just the last person to add a device to a system is responsible; you clearly have the wrong impression Geoff.

Medical Devices CE marking is a costly business, I would wager that the cost of redesign to comply with the EMC directive is the main reason why any manufacturer would think twice.

And the view that a Manufacturer can suggest that its okay leave it to the EBME Dept to connect it, and thus devolve a Manufacturer from responsibility is flawed for obvious reasons.