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.
List of critical medical devices and information to be provided
1. Immediately following the recognition of a public health emergency, the MDSSG shall consult the working party referred to in Article 21(5). Immediately following that consultation, the MDSSG shall adopt a list of categories of critical medical devices which it considers to be critical during the public health emergency (‘public health emergency critical devices list’).
To the extent possible, relevant information on critical medical devices and related manufacturers shall be gathered from Eudamed, once it is fully functional. The information shall also be gathered from importers and distributors, as appropriate. Until Eudamed is fully functional, available information may also be gathered from national databases or other available sources.
The MDSSG shall update the public health emergency critical devices list whenever necessary until the termination of the recognition of the public health emergency.
2. For the purposes of Article 25(2), the MDSSG shall adopt and make publicly available the set of information referred to in Article 25(2), points (b) and (c), that is necessary to monitor the supply of and demand for medical devices included on the public health emergency critical devices list, and inform the working party referred to in Article 21(5) of that set of information.
3. The Agency shall publish on a dedicated webpage on its web portal:
(a)
the public health emergency critical devices list, as well as any updates to that list; and
(b)
information on actual shortages of critical medical devices included on the public health emergency critical devices list.
Monitoring shortages of medical devices on the public health emergency critical devices list
1. During a public health emergency the MDSSG shall monitor the supply of and demand for medical devices included on the public health emergency critical devices list, with a view to identifying any actual or potential shortages of those medical devices. The MDSSG shall conduct such monitoring using the public health emergency critical devices list and the information and data provided in accordance with Articles 26 and 27.
For the purposes of the monitoring referred to in the first subparagraph of this paragraph, where relevant, the MDSSG shall liaise with the MDCG, the HSC and any other relevant advisory committee on public health emergencies established pursuant to Union law.
2. For the purposes of the monitoring referred to in paragraph 1 of this Article, the MDSSG may make use of data from device registries and databases where such data is available to the Agency. In so doing, the MDSSG may take into account the data generated pursuant to Article 108 of Regulation (EU) 2017/745 and Article 101 of Regulation (EU) 2017/746.
Reporting and recommendations on shortages of medical devices
1. For the duration of the public health emergency, the MDSSG shall regularly report the results of the monitoring referred to in Article 23 to the Commission and the single points of contact referred to in Article 25(2), point (a), and, in particular, shall signal any actual or potential shortages of medical devices included on the public health emergency critical devices list.
2. Where requested by the Commission, Member States or one or more single point of contact referred to in Article 25(2), point (a), the MDSSG shall provide aggregated data and demand forecasts to support its findings and conclusions.
For the purposes of the first subparagraph, the MDSSG shall liaise with the ECDC to obtain epidemiological data to help forecast medical device needs, and with the MSSG where medical devices included on the public health emergency critical devices list are used jointly with a medicinal product.
The findings and conclusions of the MDSSG referred to in the first subparagraph may be made available to other actors in the medical device sector, where appropriate, in accordance with competition law, with a view to better preventing or mitigating or actual or potential shortages.
3. As part of the reporting referred to in paragraphs 1 and 2, the MDSSG may provide recommendations on measures that the Commission, Member States, medical device manufacturers, notified bodies and other entities could take to prevent or mitigate actual or potential shortages of medical devices.
For the purposes of the first subparagraph, the MDSSG shall liaise, where relevant, with the MDCG, with the HSC and with any other relevant advisory committee on public health emergencies established pursuant to Union law.
4. The MDSSG, on its own initiative or at the request of the Commission, may provide recommendations on measures that the Commission, Member States, manufacturers of medical devices, notified bodies and other entities could take to ensure preparedness for dealing with actual or potential shortages of medical devices caused by public health emergencies.
5. Where requested by the Commission, the MDSSG may coordinate measures taken by the national competent authorities for medical devices, manufacturers of medical devices, notified bodies, and other entities, as relevant, to prevent or mitigate actual or potential shortages of medical devices in the context of a public health emergency or major event.
Working methods and provision of information on medical devices
1. In order to prepare for the fulfilment of the tasks referred to in Articles 22, 23 and 24, the Agency shall:
(a)
specify the procedures and criteria for establishing and reviewing the public health emergency critical devices list.;
(b)
develop streamlined IT monitoring and reporting systems, in coordination with the relevant national competent authorities, that facilitate interoperability with existing IT tools and Eudamed, once it is fully functional, and provide the adequate support to national competent authorities for monitoring and reporting;
(c)
establish the working party referred to in Article 21(5) and ensure that each Member State is represented on that working party;
(d)
specify the methods for the provision of recommendations referred to in Article 24(3) and (4) and for the coordination of measures referred to in Article 24.
For the purposes of the first subparagraph, point (a), the MDCG, representatives of manufacturers, other relevant actors in the supply chain for the medical device sector and representatives of healthcare professionals, of patients and consumers may be consulted as necessary.
2. Following the recognition of a public health emergency, the Agency shall:
(a)
establish a list of single points of contact for the manufacturers of medical devices, or their authorised representatives, importers and notified bodies, for the medical devices included on the public health emergency critical devices list;
(b)
maintain the list of single points of contact referred to in point (a) for the duration of the public health emergency;
(c)
request relevant information on medical devices included on the public health emergency critical devices list from the single points of contact referred to in point (a) on the basis of the set of information adopted by the MDSSG and set a deadline for the submission of that information;
(d)
request relevant information on medical devices included on the public health emergency critical devices list from the single points of contact referred to in Article 21(5), second subparagraph, on the basis of the set of information adopted by the MDSSG in accordance with Article 22(2) and set a deadline for the submission of that information.
The Agency may use sources other than those referred to in the first subparagraph, including existing databases and databases in development, to gather information required under paragraph 3.
For the purposes of the first subparagraph, point (a), where it is considered relevant, national or Union databases, including Eudamed, once it is fully functional, or medical device associations may be used as sources of information.
3. The information referred to in paragraph 2, point (c), shall include at least:
(a)
the name of the manufacturer of the medical device and, if applicable, the name of its authorised representative;
(b)
the information identifying the medical device and the intended purpose and where necessary, specific characteristics of the medical device;
(c)
if applicable, the name and number of the notified body and information regarding the relevant certificate or certificates;
(d)
details of the actual or potential shortage of the medical device, such as actual or estimated start and end dates and the suspected or known cause;
(e)
sales and market share data of the medical device;
(f)
available stocks of the medical device;
(g)
the forecast of supply of the medical device, including information on the potential vulnerabilities in the supply chain;
(h)
quantities already delivered and projected deliveries of the medical device;
(i)
the demand forecasts for the medical device;
(j)
shortage prevention and mitigation plans that include, at a minimum, information on production and supply capacity;
(k)
information from relevant notified bodies regarding their capacity to process applications and carry out and complete conformity assessments in relation to medical devices included in the public health emergency critical devices list, within an appropriate period of time considering the emergency;
(l)
information on the number of applications received by relevant notified bodies in relation to medical devices included in the public health emergency critical devices list and on the relevant conformity assessment procedures;
(m)
where conformity assessments are ongoing, the status of the conformity assessment by the relevant notified bodies in relation to medical devices included in the public health emergency critical devices list and possible critical issues on the final outcome of the assessment and which need to be considered in order to complete the conformity assessment process.
For the purposes of the first subparagraph, point (k), the relevant notified bodies shall communicate the date by which the assessment is expected to be completed. In that regard, notified bodies shall prioritise conformity assessments of medical devices included in the public health emergency critical devices list.
Obligations on manufacturers of medical devices, authorised representatives, importers, distributors and notified bodies
1. In order to facilitate the monitoring referred to in Article 23, the Agency may request manufacturers of medical devices, or their authorised representatives, as applicable, and, if appropriate, importers and distributors, included on the public health emergency critical devices list and, where necessary, relevant notified bodies, to submit the information requested by a deadline set by the Agency.
The manufacturers of medical devices, or their authorised representatives, as applicable, and, if appropriate, importers and distributors, referred to in the first subparagraph, shall submit the requested information through the single points of contact referred to in Article 25(2), point (a), using the monitoring and reporting systems established pursuant to Article 25(1), point (b). They shall provide updates where necessary.
2. Manufacturers of medical devices, or their authorised representatives, as applicable, notified bodies and, if appropriate, importers or distributors shall justify any failure to provide requested information and any delays in providing requested information by the deadline set by the Agency.
3. Where manufacturers of medical devices, or their authorised representatives, notified bodies, or, if appropriate, importers or distributors indicate that the information that they submitted contains information of a commercially confidential nature, they shall identify the relevant parts of that information having such nature and explain why that information is of a commercially confidential nature.
The Agency shall assess the merits of each indication of information as being of a commercially confidential nature and protect such commercially confidential information against unjustified disclosure.
4. Where manufacturers of medical devices, or their authorised representatives, notified bodies, or, if appropriate, importers or distributors have any information in addition to that required under paragraph 1, which provides evidence of an actual or potential shortage of medical devices, they shall immediately provide such information to the Agency.
5. Following the reporting on the results of the monitoring referred to in Article 23 and any recommendations on preventive or mitigating measures provided in accordance with Article 24, manufacturers of medical devices, or their authorised representatives, and, if appropriate, importers and distributors referred to in paragraph 1, shall:
(a)
provide any comments they have to the Agency;
(b)
take into account any recommendations referred to in Article 24(3) and (4) and any guidelines referred to in Article 28, point (b);
(c)
comply with any measures taken at Union or Member State level pursuant to Article 27 or 28;
(d)
inform the MDSSG of any measures taken and report on the results of those measures, including providing information on the resolution of the actual or potential shortage of medical devices.
6. Where manufacturers of medical devices referred to in paragraph 1 are established outside the Union, the information requested in accordance with this Article shall be provided by the authorised representatives, or, if appropriate, by importers or distributors.
Role of Member States in the monitoring and mitigation of shortages of medical devices
1. In order to facilitate the monitoring referred to in Article 23, the Agency may request a Member State to:
(a)
submit the set of information referred to in Article 22(2), including available information about needs related to the medical devices included in the public health emergency critical devices list, and available and estimated data on volume of demand and demand forecasts for those medical devices, through the respective single point of contact referred to in Article 25(2), point (a), and using the monitoring and reporting methods and systems established pursuant to Article 25(1), point (b);
(b)
indicate the existence of any commercially confidential information and explain why that information is of a commercially confidential nature, in accordance with Article 26(3);
(c)
indicate any failure to provide requested information and whether there are any delays in providing that information by the deadline set by the Agency in accordance with Article 26(2).
Member States shall comply with the Agency’s request by the deadline set by the Agency.
2. For the purposes of paragraph 1, Member States shall gather information from manufacturers of medical devices and their authorised representatives, healthcare providers, importers and distributors, as applicable, and notified bodies on medical devices included on the public health emergency critical devices list.
3. Where Member States have any information in addition to the information to be provided in accordance with paragraphs 1 and 2 of this Article, which provides evidence of an actual or potential shortage of medical devices, they shall immediately provide such information to the MDSSG through their respective single point of contact referred to in Article 25(2), point (a).
4. Following the reporting on the results of the monitoring referred to in Article 23 and any recommendations on preventive or mitigating measures provided in accordance with Article 24, Member States shall:
(a)
consider the need to provide for temporary exemptions at Member State level pursuant to Article 59(1) of Regulation (EU) 2017/745 or Article 54(1) of Regulation (EU) 2017/746 with a view to mitigating actual or potential shortages of medical devices included on the public health emergency critical devices list while ensuring a high level of patient and product safety;
(b)
take into account any recommendations referred to in Article 24(3) and any guidelines referred to in Article 28, point (b), and coordinate their actions in relation to any actions taken at Union level pursuant to Article 12, point (a);
(c)
inform the MDSSG of any measures taken and report on the results of the actions referred to in point (b), including providing information on the resolution of the actual or potential shortage of medical devices concerned.
For the purposes of the first subparagraph, points (b) and (c), Member States that take an alternative course of action at national level shall share the reasons for doing so with the MDSSG.
The recommendations, guidelines and actions referred to in the first subparagraph, point (b), of this paragraph, and a summary report of the lessons learned shall be made publicly available via the web portal referred to in Article 29.
Role of the Commission regarding the monitoring and mitigation of shortages of medical devices
The Commission shall take into account the information from and recommendations of the MDSSG and shall:
(a)
take all necessary action within the limits of the powers conferred on the Commission, with a view to mitigating actual or potential shortages of medical devices included on the public health emergency critical devices list, including, where necessary, granting temporary exemptions at Union level pursuant to Article 59(3) of Regulation (EU) 2017/745 or Article 54(3) of Regulation (EU) 2017/746, while respecting the conditions set out in those Articles and seeking to ensure both patient and product safety;
(b)
consider the need for guidelines and recommendations to be addressed to Member States, manufacturers of medical devices, notified bodies, and other entities, where relevant;
(c)
request the MDSSG to provide recommendations or coordinate measures provided for in Article 24(3), (4) and (5);
(d)
consider the need for medical countermeasures in accordance with Decision No 1082/2013/EU and other applicable Union law;
(e)
liaise with third countries and relevant international organisations, as appropriate, to mitigate actual or potential shortages of medical devices included on the public health emergency critical devices list or their component parts, where those devices or parts of such devices are imported into the Union, and where such actual or potential shortages have international implications, and report on any related actions as well as the results of those actions to the MDSSG, where relevant.
1. The Agency shall provide information to the public and relevant interest groups with regard to the work of the MDSSG in a timely manner and shall respond to disinformation targeting the work of the MDSSG, as appropriate, via a dedicated webpage on its web portal and other appropriate means, in cooperation with national competent authorities.
2. Proceedings of the MDSSG shall be transparent.
The summaries of the agenda and of the minutes of the meetings of the MDSSG, as well as its rules of procedure referred to in Article 21(4) and recommendations referred to in Article 24(3) and (4), shall be documented and made publicly available on the dedicated webpage on the Agency web portal.
Where the rules of procedure referred to in Article 21(4) allow members of the MDSSG to have divergent opinions recorded, the MDSSG shall make such divergent opinions, and the grounds on which they are based, available to national competent authorities at their request.
From 1 March 2022, on behalf of the Commission, the Agency shall provide the secretariat for the expert panels designated in accordance with Article 106(1) of Regulation (EU) 2017/745 (the ‘expert panels’) and shall provide the support necessary to ensure that those expert panels can efficiently perform the tasks set out in Article 106(9) and (10) of that Regulation.
The Agency shall:
(a)
provide administrative and technical support to the expert panels for the provision of scientific opinions, views and advice;
(b)
facilitate and manage remote and physical meetings of the expert panels;
(c)
ensure that the work of the expert panels is carried out in an independent manner in accordance with Article 106(3), second subparagraph, and Article 107 of Regulation (EU) 2017/745 and with the systems and procedures established by the Commission pursuant to that Regulation to actively manage and prevent potential conflicts of interest in accordance with Article 106(3), third subparagraph, of that Regulation;
(d)
maintain and regularly update a webpage for the expert panels and make all necessary information not already publicly available in Eudamed publicly available on that webpage in order to ensure the transparency of the activities of the expert panels, including providing the justifications of notified bodies where those bodies did not follow the advice of the expert panels provided pursuant to Article 106(9) of Regulation (EU) 2017/745;
(e)
publish the scientific opinions, views and advice of the expert panels while ensuring confidentiality in accordance with Article 106(12), second subparagraph, and Article 109 of Regulation (EU) 2017/745;
(f)
ensure that remuneration and expenses are provided to the experts in accordance with implementing acts adopted by the Commission pursuant to Article 106(1) of Regulation (EU) 2017/745;
(g)
monitor compliance with the expert panels’ common rules of procedure and available guidelines and methodologies relevant to the functioning of the expert panels;
(h)
provide annual reports to the Commission and the MDCG on the work of the expert panels, including information on the number of opinions delivered and the views and advice provided by the expert panels.
