Executive Steering Group on Shortages of Medical Devices

The role of the European Medicines Agency's (EMA) Executive Steering Group on Shortages of Medical Devices is to ensure a robust response to supply issues with medical devices caused by public health emergencies. It puts in place measures to prevent and correct medical device shortages within the European Union (EU). 

EMA established the group in March 2023 in line with the Regulation on EMA's Reinforced Role (Regulation (EU) 2022/123). For more information, see Crisis preparedness and management.

The group is also known as the 'Medical Device Shortages Steering Group' or MDSSG. 

Responsibilities

The group's responsibilities include:

• establishing a list of critical medical devices that need to be monitored in order to prevent or manage any supply issues during a public health emergency;
• monitoring the supply of and demand for these critical medical devices to enable swift and coordinated measures to identify, prevent or mitigate potential or actual shortages;
• reporting and providing recommendations on related measures and mitigation plans;
• providing recommendations on actions needed at EU level to address any shortages of listed critical medical devices. 

How the group works

In carrying out its responsibilities, the group consults its working party on any scientific issue related to their specific fields of expertise.

It may also consult: 

• other EMA scientific committees, their working parties, expert groups and the [node:12622:link]{Coordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh) as Link};
• Health Security Committee (HSC), Medical Devices Coordination Group (MDCG), European Centre for Disease Prevention and Control (ECDC) and any other relevant advisory committee on public health emergencies.

EMA ensures that the group cooperates closely with the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG), which it established in March 2022.

The group will be supported by the Medical Device Shortages Single Points of Contact Working Party (MD-SPOC WP). This working party will bring together single points of contact for shortages from national competent authorities for medical devices.

Composition

The members of the group include:

• representatives of EU Member States;
• one representative of the European Commission;
• one EMA representative.

It also includes one observer from EMA’s Patients' and Consumers' Working Party and one from its Healthcare Professionals’ Working Party (HCPWP).

The group is co-chaired by the representative of EMA and that of one Member State.

More information on the group's responsibilities, composition, procedures and activities is available below:

Rules of procedure of the Executive Steering Group on Shortages of Medical Devices

Members

The group is co-chaired by: 

• Emer Cook, EMA
• Karl Broich, Federal Institute for Drugs and Medical Devices - BfArM, Germany