Medical devices: new guidance for industry and notified bodies

Name: Medical devices: new guidance for industry and notified bodies
Creator: European Medicines Agency
Keywords: changes,diagnostics,eu,european-union,guidances,implementation,in-vitro-diagnostic-medical-devices,in-vitro-diagnostics,industry,ivd,ivdmd,ivds,mdr,medical-devices,medical-devices-regulations,news,notified-bodies,q-a,questions-and-answers,regulations,tracking

Information

Original link

Type

News

Regulated products

IVDMD, Medical Devices

Last updated

May 21, 2024

Description

A document providing updated guidance for the medical device industry and notified bodies.

Organization

European Medicines Agency (EMA) 🇪🇺

Country / Region

European Union

License

Other (Public Domain)

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2 Main files

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/4acc01f8-25f3-494a-af5a-5bc5838c9e21
MIME Type: application/pdf

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

EMA/37991/2019 Rev.4

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