Questions & Answers for applicants, marketing authorisation holders of medicinal products and notified bodies with respect to the implementation of the Medical Devices and In Vitro Diagnostic Medical Devices Regulations ((EU) 2017/745 and (EU) 2017/746)

Name: Questions & Answers for applicants, marketing authorisation holders of medicinal products and notified bodies with respect to the implementation of the Medical Devices and In Vitro Diagnostic Medical Devices Regulations ((EU) 2017/745 and (EU) 2017/746)
Creator: European Commission
License: https://creativecommons.org/licenses/by/4.0/
Keywords: authorization,diagnostics,eu,european-union,guidances,implementation,in-vitro-diagnostic-medical-devices,in-vitro-diagnostics,ivd,ivdmd,ivds,marketing,marketing-authorization,mdr,medical-devices,medical-devices-regulations,medicinal-products,medicines,notified-bodies,regulations

Information

Type

Guidance

Regulated products

IVDMD, Medical Devices

Topics

Published

June 1, 2021

Last updated

June 1, 2021

Description

Document provides guidance for applicants, marketing authorization holders, and notified bodies on implementing EU Medical Devices Regulations (2017/745 and 2017/746).

Organization

European Commission 🇪🇺

Country / Region

European Union

License

Creative Commons Attribution 4.0

Feedback

Suggest an improvement to this page

1 Main file

European Medicines Agency (EMA) Guidance

Updated on May 15, 2024

none

URL: https://www.ema.europa.eu/en/human-regulatory/overview/medical-devices
Permalink: https://data.openrid.co/en/datasets/r/2d4e501e-3469-48f5-a24a-435a0fe04220
MIME Type: None

Created on: May 15, 2024
Modified on: May 15, 2024