Make a submission – medical devices

Device schedule for certificates of free sale for medical devices XLSX : 22 KB | 30/01/2025 Application for certificates for free sale for medical devices DOCX : 130 KB | 30/01/2025 Fee application form for human products XLSX : 84 KB | 02/01/2025 Consultant application for compassionate use of a non-CE marked medical device or IVD DOCX : 106 KB | 14/04/2024 Article 97 Request Form DOCX : 115 KB | 10/02/2023 Notification of a PS for a companion diagnostic under Article 58(2) DOCX : 115 KB | 19/06/2022 Notification of a PS of a CE marked IVD under Article 70 DOCX : 119 KB | 19/06/2022 Notification of a clinical investigation of a CE marked medical device (Article 74 MDR) DOCX : 117 KB | 07/06/2022 Notification of substantial modification of a clinical investigation of a medical device DOCX : 82 KB | 07/06/2022 Request for performance study pre-submission meeting DOCX : 102 KB | 18/05/2022 Application for a performance study DOCX : 125 KB | 16/05/2022 Application for a clinical investigation of non CE-marked medical devices (Article 62 MDR) DOCX : 125 KB | 16/05/2022 Notification of a clinical investigation under Article 82 MDR DOCX : 120 KB | 29/03/2022 Request for classification of a human health product DOCX : 110 KB | 16/02/2022 Manufacturer application for compassionate use of a non-CE marked medical device DOCX : 102 KB | 30/01/2021 Application form to be submitted when applying for designation as a Notified Body DOCX : 109 KB | 18/08/2020 Request for clinical investigation pre-submission meeting DOCX : 108 KB | 31/01/2020 Medical device incident user report DOCX : 105 KB | 16/10/2019 Designation of Notified Bodies - Application Documentation Index Form DOCX : 102 KB | 26/11/2017 Declaration of completeness of Application Form DOCX : 54 KB | 26/11/2017