Is anyone aware of any EU regulations, directives or guidance similar to the new FDA guidance on combination products?
Alan Pipe on behalf of the GMP Committee 09/05/2013 12:03
Generally speaking we don’t think there is a legal definition of a combination product in the EU (in the US there is a legal definition). Basically you start with the medical devices directives 93/42/EEC and 2007/47/EU. The latter introduces the concept of primary mode of action. If you determine that your product’s PMOA is a medicinal product (e.g. an inhaler or pre-filled injector) then 2001/83/EC applies with the MDD Essential Requirements for the device.
Guidance on the MDD can be found in the EU meddev documents, and the NB-MED document published by the Notified Bodies.
The most comprehensive guidance there is currently on ‘combination products’ is the following…but it’s not much!