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)

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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

NEAK határozat kérelem nyomtatvány – rendelésre készült eszköz

Updated on June 24, 2024

doc

URL: https://ogyei.gov.hu/dynamic/ny_e7_1_mdr_kerelem__neakhat_nyomtatvany_v13.doc
Permalink: https://data.openrid.co/en/datasets/r/29b84661-c5cd-4837-96cf-6e220846e0e6
MIME Type: application/msword

Created on: May 13, 2024
Modified on: June 24, 2024

Teljesítőképesség-értékelési vizsgálat - az in vitro diagnosztikai orvostechnikai eszközökről szóló rendelet (IVDR) szerinti bejelentési űrlap/Performance study - application/notification form under In Vitro Diagnostic Medical Devices Regulation (IVDR)

Updated on June 24, 2024

pdf

URL: https://ogyei.gov.hu/dynamic/performance_study_application_form_hu.pdf
Permalink: https://data.openrid.co/en/datasets/r/3224279b-35cc-497b-b440-340309ab9cee
MIME Type: application/pdf

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

Section 3: Device for performance study

Updated on June 24, 2024

pdf

URL: https://ogyei.gov.hu/dynamic/section_3_additional_devices.pdf
Permalink: https://data.openrid.co/en/datasets/r/f86d2131-9a5e-4818-9658-328b4c226526
MIME Type: application/pdf

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

Section 4: Comparator

Updated on June 24, 2024

pdf

URL: https://ogyei.gov.hu/dynamic/section_4_additional_comparator.pdf
Permalink: https://data.openrid.co/en/datasets/r/df01d9c3-4971-4cb5-acd4-6f916bb6d705
MIME Type: application/pdf

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

Section 5: National information

Updated on June 24, 2024

pdf

URL: https://ogyei.gov.hu/dynamic/section_5_additional_sites.pdf
Permalink: https://data.openrid.co/en/datasets/r/94616ff4-4c1c-4454-ac86-90492e7d265e
MIME Type: application/pdf

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

IVDR szerinti teljesítőképesség-értékelési vizsgálat – Mellékletek/Annexes

Updated on June 24, 2024

docx

URL: https://ogyei.gov.hu/dynamic/mellekletek_annexes.docx
Permalink: https://data.openrid.co/en/datasets/r/cfd6e782-5541-42a0-84a2-4f5b57f89408
MIME Type: application/vnd.openxmlformats-officedocument.wordprocessingml.document

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

IVDD forgalmazói nyilvántartásba vétel – I-form

Updated on June 24, 2024

xlsx

URL: https://ogyei.gov.hu/dynamic/forgalmazoi_reg_ivdd_ala_tartozo_ivd_eszkoz_fin_1.xlsx
Permalink: https://data.openrid.co/en/datasets/r/cf208878-a67d-4f77-abba-b2cb5a139655
MIME Type: application/vnd.openxmlformats-officedocument.spreadsheetml.sheet

Created on: May 28, 2024
Modified on: June 24, 2024

IVDR forgalmazói nyilvántartásba vétel – I-form

Updated on June 24, 2024

xlsx

URL: https://ogyei.gov.hu/dynamic/forgalmazoi_reg_ivdr_ala_tartozo_ivd_eszkoz_fin_0511_1.xlsx
Permalink: https://data.openrid.co/en/datasets/r/0255970e-0298-4ab6-b199-d13b68836db0
MIME Type: application/vnd.openxmlformats-officedocument.spreadsheetml.sheet

Created on: May 28, 2024
Modified on: June 24, 2024

MDR/IVDR szerinti nyomtatványok

Updated on June 24, 2024

html

URL: https://ogyei.gov.hu/formanyomtatvanyok_orvostechnika
Permalink: https://data.openrid.co/en/datasets/r/69c2bea2-4a6a-4ab2-a87a-ee4d53a243e7
MIME Type: text/html

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

MDR/IVDR forms

Information

Type

Regulated products

Last updated

Description

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Organization

Country / Region

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