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Make a submission – medical devices

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 : 95 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

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

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

Declaration of completeness of Application Form

DOCX : 54 KB | 26/11/2017

Application for a drug-device consultation

DOCX : 90 KB | 02/06/2008