Make a submission – medical devices Fee application form for human products XLSX : 91 KB | 02/01/2026 Device schedule for certificates of free sale for medical devices XLSX : 32 KB | 07/05/2025 Application for certificates for free sale for medical devices DOCX : 96 KB | 30/01/2025 Notification form for in-house manufacturers Submit online form | 28/01/2025 Opens in new window Registration form for medical device economic operators Submit online form | 28/01/2025 Opens in new window Innovation office enquiry Submit online form | 28/01/2025 Opens in new window Manufacturer application for compassionate use of a non-CE marked medical device or IVD DOCX : 75 KB | 14/04/2024 Consultant application for compassionate use of a non-CE marked medical device or IVD DOCX : 71 KB | 14/04/2024 Notification of a PS of a CE marked IVD under Article 70 DOCX : 120 KB | 19/06/2022 Notification of a PS for a companion diagnostic under Article 58(2) DOCX : 116 KB | 19/06/2022 Notification of substantial modification of a clinical investigation of a medical device DOCX : 82 KB | 07/06/2022 Notification of a clinical investigation of a CE marked medical device (Article 74 MDR) DOCX : 117 KB | 07/06/2022 Application for a clinical investigation of non CE-marked medical devices (Article 62 MDR) DOCX : 91 KB | 07/06/2022 Request for performance study pre-submission meeting DOCX : 104 KB | 18/05/2022 Application for a performance study DOCX : 127 KB | 16/05/2022 Notification of a clinical investigation under Article 82 MDR DOCX : 87 KB | 29/03/2022 Application form to be submitted when applying for designation as a Notified Body DOCX : 80 KB | 18/08/2020 Request for clinical investigation pre-submission meeting DOCX : 74 KB | 31/01/2020 Declaration of completeness of Application Form DOCX : 56 KB | 26/11/2017 Application for a drug-device consultation DOCX : 90 KB | 02/06/2008
