The strengthened mandate of the European Medicines Agency (EMA) came into full effect on 2 February. The last provisions of this mandate, Chapter IV of Regulation (EU) 2022/123, with the exception of Article 30, entered into force on 2 February.
At the same time, the Agency announced the upcoming establishment of a Medical Devices Shortages Steering Group (MDSSG).
Following the same model as the Steering Group on Shortages and Safety of Medicinal Products (MSSG) (see EUROPE 12952/8) with which it will collaborate, the MDSSG will coordinate actions to be taken with regard to the management of tensions and shortages of critical medical devices and implantable devices in the EU in the event of a public health emergency.
The MDSSG will be able to make recommendations to stakeholders, institutions, Member States and notified bodies.
The steering group will be composed of one representative of the EMA, one representative of the European Commission and one representative of each Member State. It will be co-chaired by the EMA and a Member State representative. A representative of the EMA Patients’ and Consumers’ Working Party and a representative of the Healthcare Professionals Working Party will also be invited as observers.
The MDSSG will adopt lists of critical medical devices for public health emergencies.
Manufacturers, authorised representatives, importers, distributors of listed critical medical devices will be required to register their single point of contact (EO-SPOC) through the EMA’s IRIS platform. This will facilitate the exchange of information, in particular on the state of supply and demand, and complement the information obtained via the Member States.
The MD-SPOC Working Party will assist the MDSSG and will do so through a sub-network of SPOCs consisting of medical device manufacturers, suppliers, economic operators (EOs) and notified bodies. (Original version in French by Émilie Vanderhulst)