How do I apply for marketing approval for a device that may contain an ATMP?
Combined ATMPs will be evaluated by the EMEA. The application for a marketing authorisation or a combined ATMP which contains a medical device should include evidence that the device meets the essential requirements laid down in Annex 1 to Directive 93/42/EEC or 90/385/EEC, as the case may be and, where available, the results of an assessment by a notified body in accordance with the medical devices legislation. The EMEA shall recognise the results of that assessment in its evaluation of the ATMP. If the application does not include the results of a notified body’s assessment, the EMEA will seek a notified body’s assessment unless the Committee for Advanced Therapies (CAT) advised by its experts for medical devices, decides that the involvement of a notified body is not required. Where such a device contains human cells the donation, procurement and testing of these cells falls under the remit of the HTA even if classification of the combination device has been given by the EMEA.
