Building a European Health Union: medical device shortage addressed

The European Commission presented its new Communication Building a European Health Union: Stronger crisis preparedness and response for Europe and three Proposals for a Regulation to strengthen the EU’s health security framework, and to reinforce the crisis preparedness and response role of key EU agencies:

• Proposal for a Regulation on serious cross-border threats to health
• Proposal to extend the mandate of the European Centre for Disease Prevention and Control
• Proposal to extend the mandate of the European Medicines Agency

Medical devices are specifically addressed in Chapter IV – Monitoring and mitigating shortages of critical medical devices and support for expert panel of the Proposal to extend the mandate of the European Medicines Agency, where

• The Executive Steering Group on Medical Devices is to be established as part of the EMA
  • Composed of a representative of the Agency, a representative of the Commission and one senior representative per Member State
  • The Chair may invite third parties, including representatives of medical device interest groups to attend its meetings
• ”The public health emergency critical devices list” to be created – list of medical devices which Medical Devices Steering Group considers as critical during the public health emergency
  • Immediately following the recognition of a public health emergency and after consultation of its working party
  • List to be updated when necessary and published on the web-portal
• The Medical Devices Steering Group shall monitor supply and demand of medical devices included on the list with a view to identifying any potential or actual shortages of those medical devices
  • May also make use of data from device registries and databanks where such data is available to the Agency, including data generated pursuant to Article 108 of Regulation (EU) 2017/745 and Article 101 of Regulation (EU) 2017/746.
• The Medical Devices Steering Group shall regularly report the results of its monitoring to the Commission and the sub-network and signal any potential or actual shortages of medical devices included on the public health emergency critical devices list
• Working methods and provision of information on medical devices are explained (Article 23)
• Obligations on medical device manufacturers, authorised representatives, and notified bodies
  • Manufacturers of the medical devices included on the public health emergency critical devices list and, where necessary, concerned notified bodies, shall submit the information requested by the deadline set by the Agency. They shall submit the information requested through the points of contact and using reporting methods referred in Article 23 of the Proposal to the Regulation.
  • If submitted information contains information of a commercially confidential nature, manufacturers shall identify the relevant parts and clarify the reasons for such an indication. The Agency shall assess the merits of each request and protect such commercially confidential information against unjustified disclosure.
  • Manufacturers and notified bodies shall immediately share any additional information, which provides evidence of a potential or actual shortage.
  • Provide comments, and inform Agency of any measures taken; as well as comply with guidelines and measures taken at Union and Member State-level in accordance with Article 25 and 26 of the Proposal to the Regulation.

• The  Agency  shall provide  the secretariat  of  the  expert  panels  designated  in  accordance  with  Implementing  Decision  (EU) 2019/1396  and  provide  the  support  necessary  to ensure  that  those  panels  can  efficiently perform  their  tasks  as  set  out  in  Article  106(9)  and  (10)  of  Regulation  (EU)  2017/745 (from  1  March  2022    onwards).

The Proposal also encourages the EU Member States to authorize 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 to mitigate the shortage of medical devices included on the public health emergency critical devices list (”Derogation from the conformity assessment procedures”).

More information can be found on the European Commission website.

Communication: Building a European Health Union – preparedness and resilience

Factsheet – A European Health Union – tackling health crises together

Factsheet – A European Health Union – the role of agencies