Multi-stakeholder webinar to support implementation of the Medical Devices Regulation on drug-device combinations

Name: Multi-stakeholder webinar to support implementation of the Medical Devices Regulation on drug-device combinations
Creator: European Medicines Agency
Keywords: changes,considerations,drug-device,events,feedback,implementation,industry,lifecycle,mdr,medical-devices,medical-devices-regulations,notified-bodies,regulations,substantial,support,webinar

Information

Original link

Type

Event

Regulated products

Medical Devices

Last updated

January 22, 2021

Description

Webinar to aid implementation of Medical Devices Regulation on drug-device combinations for multiple stakeholders.

Organization

European Medicines Agency (EMA) 🇪🇺

Country / Region

European Union

License

Other (Public Domain)

Feedback

Suggest an improvement to this page

8 Main files

Agenda - Multi-stakeholder webinar to support implementation of Article 117 of the MDR 2017/745 on drug-device combinations

Updated on November 27, 2020

pdf

URL: https://www.ema.europa.eu/en/documents/agenda/agenda-multi-stakeholder-webinar-support-implementation-article-117-mdr-2017745-drug-device-combinations_en.pdf
Permalink: https://data.openrid.co/en/datasets/r/722efbfe-2760-48ce-8067-d0edc211035e
MIME Type: application/pdf

Created on: November 23, 2020
Modified on: November 27, 2020

EMA/128303/2020

Presentation - Welcome and introduction - Multi-stakeholder webinar to support implementation of the Medical Devices Regulation on drug-device combinations

Updated on January 22, 2021

pdf

URL: https://www.ema.europa.eu/en/documents/presentation/presentation-welcome-and-introduction-multi-stakeholder-webinar-support-implementation-medical-devices-regulation-drug-device-combinations_en.pdf
Permalink: https://data.openrid.co/en/datasets/r/c4334bc0-d6fa-41ca-a61e-41f6409de45f
MIME Type: application/pdf

Created on: January 22, 2021
Modified on: January 22, 2021

Presentation - Team NB: Feedback on notified body opinions to date (Julia Frese, Jonathan Sutch)

Updated on January 22, 2021

pdf

URL: https://www.ema.europa.eu/en/documents/presentation/presentation-team-nb-feedback-notified-body-opinions-date-julia-frese-jonathan-sutch_en.pdf
Permalink: https://data.openrid.co/en/datasets/r/c300461f-4bdf-4d11-80ed-5494f38adbe0
MIME Type: application/pdf

Created on: January 22, 2021
Modified on: January 22, 2021

Presentation - Team NB's perspective on life cycle management under Article 117 / MDR (Petra van Leeuwen, Colm O’Rourke)

Updated on January 22, 2021

pdf

URL: https://www.ema.europa.eu/en/documents/other/presentation-team-nbs-perspective-life-cycle-management-under-article-117-mdr-petra-van-leeuwen-colm-orourke_en.pdf
Permalink: https://data.openrid.co/en/datasets/r/1638ac65-8013-4ee6-9b4f-57d4d06b6162
MIME Type: application/pdf

Created on: January 22, 2021
Modified on: January 22, 2021

Presentation - Lifecycle management: Substantial and non-substantial changes for drug-device combinations (Amanda Matthews, Tim Chesworth)

Updated on January 22, 2021

pdf

URL: https://www.ema.europa.eu/en/documents/presentation/presentation-lifecycle-management-substantial-and-non-substantial-changes-drug-device-combinations-amanda-matthews-tim-chesworth_en.pdf
Permalink: https://data.openrid.co/en/datasets/r/77e664c6-448d-4874-9170-cda22f29fc81
MIME Type: application/pdf

Created on: January 22, 2021
Modified on: January 22, 2021

Presentation - The notified body opinion: Industry experiences (Bjorg Hunter)

Updated on January 22, 2021

pdf

URL: https://www.ema.europa.eu/en/documents/presentation/presentation-notified-body-opinion-industry-experiences-bjorg-hunter_en.pdf
Permalink: https://data.openrid.co/en/datasets/r/660de4b8-77fb-48ee-be21-a147329e9fc3
MIME Type: application/pdf

Created on: January 22, 2021
Modified on: January 22, 2021

See the 8 main files

Multi-stakeholder webinar to support implementation of the Medical Devices Regulation on drug-device combinations

Information

Type

Regulated products

Last updated

Description

Tags

Organization

Country / Region

License

Feedback

Actions

Social networks

Embed