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1. The Executive Steering Group on Shortages of Medical Devices (the ‘Medical Device Shortages Steering Group – MDSSG’) is hereby established within the Agency. The MDSSG shall be responsible for fulfilling the tasks referred to in Articles 22, 23 and 24. The MDSSG shall meet regularly and also whenever the situation requires, either in person or remotely, in preparation for or during a public health emergency. The Agency shall provide the secretariat of the MDSSG.

2. The members of the MDSSG shall consist of a representative of the Agency, a representative of the Commission and one representative appointed by each Member State. The representatives of the Member States shall have expertise in the field of medical devices, as relevant. Those representatives may be the same as the representatives appointed to the Medical Devices Coordination Group established by Article 103 of Regulation (EU) 2017/745 (‘MDCG’), where appropriate. Members of the MDSSG may be accompanied to meetings of the MDSSG by experts in specific scientific or technical fields.

The list of the members of the MDSSG shall be published on the Agency’s web portal. A representative of the PCWP and a representative of the HCPWP may attend meetings of the MDSSG as observers.

3. The MDSSG shall be co-chaired by the representative of the Agency and by one of the representatives of the Member States, who shall be elected by and from among the representatives of the Member States in the MDSSG. The co-chairs of the MDSSG, on their own initiative or at the request of one or more members of the MDSSG, may invite, as observers and to provide expert advice, third parties, including representatives of medical device interest groups, such as representatives of manufacturers and notified bodies, or any other relevant actor in the supply chain for medical devices, and representatives of healthcare professionals, of patients and consumers, to attend its meetings, as necessary.

4. The MDSSG shall establish its rules of procedure, including procedures relating to the working party referred to in paragraph 5 of this Article, and procedures for adoption of the lists referred to in Article 22, sets of information and recommendations referred to in Article 24(3) and (4).

The rules of procedure referred to in the first subparagraph shall enter into force once the MDSSG has received a favourable opinion from the Commission and the Management Board of the Agency.

5. The MDSSG shall be supported in its work by a working party established in accordance with Article 25(1). The working party referred to in the first subparagraph shall consist of representatives of the national competent authorities responsible for shortage monitoring and management of medical devices, who shall be the single points of contact in relation to shortages of medical devices.