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European Medicines Agency (EMA) 🇪🇺

Description

The European Medicines Agency (EMA) is a decentralised agency of the European Union (EU) responsible for the scientific evaluation, supervision and safety monitoring of medicines in the EU.

Official website

https://www.ema.europa.eu/en

Information session on the pilot for expert panels' advice for orphan medical devices

From European Medicines Agency (EMA) 🇪🇺

An upcoming event discussing a pilot program for expert panels' advice on orphan medical devices.

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Updated 2 days ago

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Medical devices

From European Medicines Agency (EMA) 🇪🇺

Medical devices are regulated at EU Member State level, but the European Medicines Agency (EMA) is involved in the regulatory process.

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Updated on May 21, 2024

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New pilot programme to support orphan medical devices

From European Medicines Agency (EMA) 🇪🇺

Announcement of a new pilot programme aimed at providing support for orphan medical devices.

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Updated on August 2, 2024

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Medical devices: new guidance for industry and notified bodies

From European Medicines Agency (EMA) 🇪🇺

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

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Updated on May 21, 2024

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GeGant

From European Medicines Agency (EMA) 🇪🇺

Information about marketing authorisation application of GeGant, a device to obtain a solution containing radioactive gallium.

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Updated on April 26, 2024

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Medical Device Shortages SPOC Working Party meetings

From European Medicines Agency (EMA) 🇪🇺

Information on Medical Device Shortages SPOC Working Party meetings.

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Updated on October 12, 2023

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Medical Device Shortages Single Point of Contact (SPOC) Working Party

From European Medicines Agency (EMA) 🇪🇺

Information on medical device shortages and Single Point of Contact (SPOC) Working Party.

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Updated on August 17, 2023

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Executive Steering Group on Shortages of Medical Devices

From European Medicines Agency (EMA) 🇪🇺

Document discussing the Executive Steering Group's efforts to address shortages of medical devices.

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Updated on May 3, 2023

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Meeting of the Executive Steering Group on Shortages of Medical Devices (MDSSG)

From European Medicines Agency (EMA) 🇪🇺

Meeting of the Executive Steering Group on Shortages of Medical Devices (MDSSG).

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Updated on July 25, 2023

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Executive Steering Group on Shortages of Medical Devices (MDSSG) meetings

From European Medicines Agency (EMA) 🇪🇺

Document discussing the meetings of the Executive Steering Group on Shortages of Medical Devices (MDSSG).

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Updated on June 15, 2023

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EMA pilots scientific advice for certain high-risk medical devices

From European Medicines Agency (EMA) 🇪🇺

EMA is testing scientific advice for high-risk medical devices.

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Updated on February 27, 2023

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Information session on the pilot for expert panels’ scientific advice to manufacturers of high-risk medical devices

From European Medicines Agency (EMA) 🇪🇺

Information session on pilot for expert panels' scientific advice to manufacturers of high-risk medical devices.

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Updated on February 24, 2023

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A new role for EMA in monitoring and mitigating critical medical device shortages during public health emergencies

From European Medicines Agency (EMA) 🇪🇺

EMA takes on new role in managing medical device shortages during public health crises.

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Updated on February 2, 2023

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Quality documentation for medicinal products when used with a medical device - Scientific guideline

From European Medicines Agency (EMA) 🇪🇺

Guideline for quality documentation of medicinal products used with medical devices.

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Updated on December 8, 2021

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Medical Device Regulation comes into application

From European Medicines Agency (EMA) 🇪🇺

Information on implementation of the Medical Device Regulation.

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Updated on May 26, 2021

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Consultation procedure for ancillary medicinal substances in medical devices

From European Medicines Agency (EMA) 🇪🇺

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

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Updated on July 31, 2023

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

From European Medicines Agency (EMA) 🇪🇺

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

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Updated on January 22, 2021

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

From European Medicines Agency (EMA) 🇪🇺

A workshop to aid the implementation of the Medical Devices Regulation on drug-device combinations.

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Updated on March 2, 2020

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Tripartite meeting held between the EMA, Food and Drug Administration (FDA) and Pharmaceuticals and Medical Devices Agency (PMDA) to discuss regulatory approaches for the evaluation of antibacterial agents

From European Medicines Agency (EMA) 🇪🇺

Tripartite meeting between EMA, FDA, and PMDA to discuss regulatory approaches for antibacterial agents evaluation.

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Updated on November 6, 2019

Other (Public Domain)

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Consultation on draft guideline on quality requirements for medical devices in combination products

From European Medicines Agency (EMA) 🇪🇺

Consultation on draft guideline for quality requirements in medical devices combined with other products.

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Updated on June 3, 2019

Other (Public Domain)

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