Combination products regulations
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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
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!