MDR/IVDR forms

Name: MDR/IVDR forms
Creator: National Institute of Pharmacy and Nutrition
Keywords: diagnostics,forms,in-vitro-diagnostics,in-vitro-diagnostics-regulation,ivd,ivdr,mdr,medical-devices,medical-devices-regulations,regulations

Information

Original link

Type

Form

Regulated products

IVDMD, Medical Devices

Last updated

June 24, 2024

Description

A document containing forms related to Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR).

Organization

National Institute of Pharmacy and Nutrition (OGYÉI) 🇭🇺

Country / Region

Hungary

License

Other (Public Domain)

Feedback

Suggest an improvement to this page

15 Main files

EU megfelelőségi nyilatkozat minta

Updated on June 24, 2024

docx

URL: https://ogyei.gov.hu/dynamic/EU_megfelelosegi_nyilatkozat_minta_0624.docx
Permalink: https://data.openrid.co/en/datasets/r/09c17edb-8671-4eae-8eef-6f586c56716c
MIME Type: application/vnd.openxmlformats-officedocument.wordprocessingml.document

Created on: May 10, 2024
Modified on: June 24, 2024

EU megfelelőségi nyilatkozat minta – RENDELÉSRE KÉSZÜLT ESZKÖZ

Updated on June 24, 2024

docx

URL: https://ogyei.gov.hu/dynamic/megfelelosegi_nyilatkozat_minta_rendelesre_keszult_v2.docx
Permalink: https://data.openrid.co/en/datasets/r/61ac1f9e-4b42-4a4b-92a4-1e926ed2577b
MIME Type: application/vnd.openxmlformats-officedocument.wordprocessingml.document

Created on: May 10, 2024
Modified on: June 24, 2024

MDR 29. cikk szerinti eszköz és UDI regisztrációs kérelem

Updated on June 24, 2024

xlsx

URL: https://ogyei.gov.hu/dynamic/MDR_29cikk_szerinti_eszköz_es_UDI_regisztracios_kerelem0803.xlsx
Permalink: https://data.openrid.co/en/datasets/r/e56f1ddc-1456-47a2-9ae0-075eab14d08a
MIME Type: application/vnd.openxmlformats-officedocument.spreadsheetml.sheet

Created on: May 10, 2024
Modified on: June 24, 2024

Útmutató az MDR 29. cikk szerinti eszköz és UDI regisztrációhoz

Updated on June 24, 2024

docx

URL: https://ogyei.gov.hu/dynamic/utmutato_az_MDR_29_cikk_szerinti_eszk%C3%B6z_es_UDI_bejelenteshez.docx
Permalink: https://data.openrid.co/en/datasets/r/bcde6bbd-ba0f-434e-9b25-3a82f0795184
MIME Type: application/vnd.openxmlformats-officedocument.wordprocessingml.document

Created on: May 10, 2024
Modified on: June 24, 2024

Rendelésre készült gyártó regisztrációs kérelem

Updated on June 24, 2024

xlsx

URL: https://ogyei.gov.hu/dynamic/rendelesre_keszult_gyarto_reg_kerelem_v11.xlsx
Permalink: https://data.openrid.co/en/datasets/r/03a219f1-fc4d-44cf-bbed-79f69e29873d
MIME Type: application/vnd.openxmlformats-officedocument.spreadsheetml.sheet

Created on: May 14, 2024
Modified on: June 24, 2024

Útmutató rendelésre készült eszköz gyártói regisztrációhoz

Updated on June 24, 2024

pdf

URL: https://ogyei.gov.hu/dynamic/utmutato_az_mdr_szerinti_rendelesre_keszult_eszkoz_regisztraciohoz_2024.pdf
Permalink: https://data.openrid.co/en/datasets/r/dc6a9a70-43fc-4aa3-af79-01bb5df06653
MIME Type: application/pdf

Created on: June 24, 2024
Modified on: June 24, 2024

See the 15 main files

MDR/IVDR forms

Information

Type

Regulated products

Last updated

Description

Tags

Organization

Country / Region

License

Feedback

Actions

Social networks

Embed