Drug-device consultations
Manufacturers of medical devices containing medicinal substances which are acting ancillary to the medical device will need to supply their Notified Body with appropriate safety, quality and usefulness data with regard to the medicinal substance contained within the device.
Notified Bodies will need to consult with one of the drug regulatory bodies within the EU or the European Medicines Agency (EMA).
Guidance on this with regard to consulting with the MHRA can be found in:
Guidance note 31 'Guidance for Notified Bodies - Devices which incorporate an ancillary medicinal substance - Consulting the MHRA
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Please note that Guidance Note 31 replaces the previously published 2003 MHRA Guidance Note 18 on this subject.
