First guidance on new rules for certain medical devices

Name: First guidance on new rules for certain medical devices
Creator: European Medicines Agency
Keywords: diagnostics,eu,european-union,guidances,implementation,in-vitro-diagnostic-medical-devices,in-vitro-diagnostics,ivd,ivdmd,ivds,mdr,medical-devices,medical-devices-regulations,news,q-a,questions-and-answers,regulations,rules

Information

Original link

Type

News

Regulated products

IVDMD, Medical Devices

Last updated

February 28, 2019

Description

Introducing new rules for specific medical devices: First guidance document released.

Organization

European Medicines Agency (EMA) 🇪🇺

Country / Region

European Union

License

Other (Public Domain)

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1 Main file

Questions and answers on implementation of the medical devices and in vitro diagnostic medical devices Regulations ((EU) 2017/745 and (EU) 2017/746)

Updated on May 21, 2024

pdf

URL: https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/questions-answers-implementation-medical-devices-vitro-diagnostic-medical-devices-regulations-eu-2017-745-eu-2017-746_en.pdf
Permalink: https://data.openrid.co/en/datasets/r/98be1f2e-6492-417f-961b-4114150e0ee0
MIME Type: application/pdf

Created on: February 28, 2019
Modified on: May 21, 2024

EMA/37991/2019 Rev.4