As of today, 2 February 2023, EMA’s additional responsibilities regarding the monitoring and mitigation of shortages of critical medical devices during public health emergencies will apply. The new provisions are the last remaining part to be implemented of Regulation (EU) 2022/123, that reinforces EMA’s role in crisis management of critical medicinal products and medical devices during public health emergencies.
The Agency is now responsible for coordinating responses of EU / EEA countries to shortages of critical medicines and medical devices including in-vitro diagnostics during public health emergencies. The Medical Devices Shortages Steering Group (MDSSG) will be set up to coordinate urgent actions within the Union in relation to the management of supply and demand issues of critical medical devices and to make recommendations to relevant stakeholders, including the European Commission, Member States and notified bodies.
Once established, the MDSSG will be responsible for adopting lists of medical devices which it considers to be critical for declared public health emergencies. These lists come with new reporting obligations for manufacturers of medical devices, authorised representatives and, if required, also for importers, distributors and notified bodies of those critical medical devices. Together with information from Member States this will enable accurate monitoring of the supply of and demand for these devices so that measures to prevent or mitigate potential and actual shortages can be taken swiftly and in a coordinated manner.
EMA will ensure that the MDSSG closely cooperates with the existing Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) established in March 2022 during public health emergencies.
The MDSSG will be supported by the Medical Device Shortages SPOC Working Party (MD-SPOC WP) comprised of Single Points of Contact (SPOCs) for shortages from National Competent Authorities for medical devices, as well as by a sub-network of SPOCs from manufacturers of medical devices, authorised representatives, importers, distributors, so-called Economic Operators (EO), and notified bodies.
The manufacturers, authorised representatives, importers, distributors of those critical medical devices included in any list of critical medical devices will need to register their single point of contact (EO-SPOC) through EMA’s IRIS platform to facilitate rapid communication during a declared public health emergency. Relevant information, including supply and demand data, will be monitored via a reporting system.
Medical devices in the EU are regulated at national level, but EMA provides scientific opinions for certain categories of Medical devices.
More on the Medical Devices Shortages Steering Group (MDSSG)
The MDSSG will be composed of a representative of the Agency, a representative of the European Commission and one representative appointed by each Member State. The MDSSG will be co-chaired by the Agency and by a representative of a Member State. A representative of the Agency’s Patients’ and Consumers’ Working Party (‘PCWP’) and Healthcare Professionals’ Working Party (‘HCPWP’) may attend meetings of the MDSSG as observer.