Devicemakers should submit a letter of intent to the European Medicines Agency at least six months in advance before they plan to seek an initial consultation on an ancillary medical substance or ancillary human blood derivative incorporated in a device, according to a new question & answer guidance.
The initial application should be submitted to the EMA using the eSubmission Gateway or the eSubmission Web Client. It also should be submitted in parallel to the appointed rapporteur, co-rapporteur and peer reviewer, using the Common European Submission Platform.
Following the consultation, devicemakers should submit Type IA, IB or Type II variations to the EMA, as well as the appointed rapporteur and co-rapporteur. Submissions should include the application, a cover letter, the procedure number and relevant documentation.