Consultation procedure for ancillary medicinal substances in medical devices

Name: Consultation procedure for ancillary medicinal substances in medical devices
Creator: European Medicines Agency
Keywords: applications,blood,consultations,forms,guidelines,human-blood,medical-devices,medicines,notified-bodies,procedures,q-a,questions-and-answers,recommendations,requirements

Information

Original link

Type

Miscellaneous

Regulated products

Medical Devices

Last updated

March 30, 2021

Description

Guidelines for consultation process on ancillary medicinal substances in medical devices.

Organization

European Medicines Agency (EMA) 🇪🇺

Country / Region

European Union

License

Other (Public Domain)

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4 Main files

EMA recommendation on the procedural aspects and dossier requirements for the consultation of the EMA by a notified body on an ancillary medicinal substance or an ancillary human blood derivative incorporated in a medical device - Revision 1

Updated on January 21, 2020

pdf

URL: https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/ema-recommendation-procedural-aspects-and-dossier-requirements-consultation-ema-notified-body-ancillary-medicinal-substance-or-ancillary-human-blood-derivative-incorporated-medical-device-revision-1_en.pdf
Permalink: https://data.openrid.co/en/datasets/r/80598e3e-40f4-400a-8873-485ee1ec18ea
MIME Type: application/pdf

Created on: January 21, 2020
Modified on: January 21, 2020

EMA/CHMP/578661/2010 Rev .1

Questions and answers on the consultation procedure to the European Medicines Agency by notified bodies on an ancillary medicinal substance or an ancillary human blood derivative incorporated in a medical device

Updated on July 31, 2023

pdf

URL: https://www.ema.europa.eu/en/documents/other/questions-and-answers-consultation-procedure-european-medicines-agency-notified-bodies-ancillary-medicinal-substance-or-ancillary-human-blood-derivative-incorporated-medical-device_en.pdf
Permalink: https://data.openrid.co/en/datasets/r/12768f10-959c-4270-b57d-162da8dc036c
MIME Type: application/pdf

Created on: December 14, 2015
Modified on: July 31, 2023

EMA/144066/2021 Rev. 2

Application form for consultation by a notified body on an ancillary medicinal substance/ancillary human blood or plasma derivative used in a medical device

Updated on March 30, 2021

doc

URL: https://www.ema.europa.eu/en/documents/template-form/application-form-consultation-notified-body-ancillary-medicinal-substanceancillary-human-blood-or-plasma-derivative-used-medical-device_en.doc
Permalink: https://data.openrid.co/en/datasets/r/f6f2e929-fdcd-486e-a27d-18ed3562fa1e
MIME Type: application/msword

Created on: February 27, 2012
Modified on: March 30, 2021

EMA/75225/2020

Application form for a post-consultation procedure on an ancillary medicinal substance in a medical device

Updated on March 30, 2021

doc

URL: https://www.ema.europa.eu/en/documents/template-form/application-form-post-consultation-procedure-ancillary-medicinal-substance-medical-device_en.doc
Permalink: https://data.openrid.co/en/datasets/r/f2939df4-4aa4-43aa-9f5c-d8e4459e8abe
MIME Type: application/msword

Created on: February 27, 2012
Modified on: March 30, 2021

EMA/75252/2020