Make a submission – medical devices

Economic Operator Form

Submit online form | 18/03/2026

Health Institution: In-house Manufacturer Notification

Submit online form | 18/03/2026

Innovation Office query

Submit online form | 13/03/2026

Submit a question to the HPRA's innovation office

Consultant application for compassionate use of a non-CE marked medical device or IVD

DOCX : 106 KB | 14/04/2024

Fee application form for human products

XLSX : 84 KB | 02/01/2024

Application for Certificates for free sale for devices qualifying under Regulation 2023-607

DOCX : 74 KB | 08/08/2023

Article 97 Request Form

DOCX : 115 KB | 10/02/2023

Application for certificates for free sale (IVDD medical devices, up classified and legacy devices)

DOCX : 110 KB | 20/12/2022

Notification of a PS of a CE marked IVD under Article 70

DOCX : 119 KB | 19/06/2022

Notification of a PS for a companion diagnostic under Article 58(2)

DOCX : 115 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 certificates for free sale (MDD medical devices system and procedure packs legacy devices)

DOCX : 108 KB | 31/05/2022

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

Application for certificates of free sale for medical devices, system and procedure packs compliant with MDR

DOCX : 105 KB | 04/02/2022

Application for certificates of free sale for in vitro diagnostic medical devices compliant with IVDR

DOCX : 106 KB | 04/02/2022