Obligations of manufacturers of custom-made devices according to the MDR

Name: Obligations of manufacturers of custom-made devices according to the MDR
Creator: National Institute of Pharmacy and Nutrition
Keywords: compliance,custom-made,custom-made-devices,manufacturers,mdr,medical-devices,medical-devices-regulations,obligations,regulations,responsibilities

Information

Original link

Type

Miscellaneous

Regulated products

Medical Devices

Last updated

June 2, 2023

Description

This document outlines the responsibilities of manufacturers of custom-made devices in compliance with the Medical Device Regulation (MDR).

Organization

National Institute of Pharmacy and Nutrition (OGYÉI) 🇭🇺

Country / Region

Hungary

License

Other (Public Domain)

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2 Main files

https://ogyei.gov.hu/dynamic/megfelelosegi_nyilatkozat_minta_rendelesre_keszult_v2.docx

Updated on June 2, 2023

docx

URL: https://ogyei.gov.hu/dynamic/megfelelosegi_nyilatkozat_minta_rendelesre_keszult_v2.docx
Permalink: https://data.openrid.co/en/datasets/r/8359e149-eedf-4e09-82bf-a393d4889f0b
MIME Type: application/vnd.openxmlformats-officedocument.wordprocessingml.document

Created on: May 10, 2024
Modified on: June 2, 2023

Rendelésre készült eszköz gyártók MDR szerinti kötelezettségei

Updated on June 2, 2023

html

URL: https://ogyei.gov.hu/rendelesre_keszult_eszkoz_gyartok_mdr_szerinti_kotelezettsegei
Permalink: https://data.openrid.co/en/datasets/r/f5bb5287-8a70-4b69-9b28-e0e5f5b53966
MIME Type: text/html

Created on: May 10, 2024
Modified on: June 2, 2023