UK MCA Fee Proposals for Drug-Device Combinations

The UK Medicines Control Agency has announced proposals for legislation enabling it to charge fees to Notified Bodies in respect of consultations required under the European Medical Devices Directive (93/42/EEC), which takes effect on January 1, 1995.

The fees will apply to drug-device combination products where the action of the medicinal substance is ancillary to that of the device, for example in the case of medicated dressings and heparin-coated catheters. The MCA notes that some unresolved questions concerning the borderline between medicines and devices remain, and these are being considered within the European Union. When decisions have been reached, guidance will be issued to companies, it says.

The MCA says its role will be to review a dossier addressing the safety, quality and usefulness of the medicinal substance in relation to the intended use of the device. The dossier will be expected to consist of expert reports, appropriate chemistry data for the active substance and information relating to the control, stability and availability of the active substance in the device. In many cases, the chemistry data would be supplied by reference to a European Drug Master File or a certificate of compliance with the quality defined by the European Pharmacopoeia. For new active substances the dossier should also include full toxicological and pharmacological documentation for the medicinal substance appropriate to the device's intended use.