This working party also provides recommendations to the European Medicines Agency's (EMA) Executive Steering Group on Shortages of Medical Devices (MDSSG) on all matters related to the monitoring and management of medical device shortages and other medical device availability issues during public health emergencies.

EMA formally established the working party in June 2023, in accordance with the Regulation on EMA's Reinforced Role (Regulation (EU) 2022/123), after the executive steering group agreed its rules of procedure.

For more information, see:

Responsibilities

The working party is responsible for the following activities:

  • Drawing up lists of medical devices that are critical during public-health emergencies, at the request of the executive steering group
  • Monitoring the demand and stock levels of those critical medical devices during the public health emergency
  • Providing advice on medical device shortage-related issues to EMA and the European Commission
  • Cooperating on shortage-related issues with international regulators

Composition

The working party is composed of single points of contact (SPOCs) for medical device shortages in the national competent authorities responsible for medical devices.

It is chaired by EMA's Head of Supply and Availability of Medicines and Devices.

The vice-chair is the single point of contact in the national competent authority of the EU Member State that holds the rotating presidency of the Council of the EU.

More information on the working party's responsibilities, composition, procedures and activities is available in this document:

Mandate, objectives and rules of procedure for the Medical Device Shortages SPOC Working Party

Reference Number: EMA/5107/20233

English (EN) (222.61 KB - PDF)

First published:
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