The European Union has adopted various new rules for emergency situations relating to public health.  These new measures build on the experience gained from the COVID-19 pandemic and give new powers to the European Commission, in close cooperation with the Member States. 

The new rules create a complex public health crisis management system.  Measures that may be adopted under this system can be far-reaching.  They include supply chain monitoring, information requests, and sometimes direct intervention of authorities in production and distribution of critical products.  The primary aim of the new rules is to ensure availability and supply of these critical products in times of crises.

This blog briefly discusses the impact of the health emergency measures on medical devices.

Background

Based on the experience with the past pandemic, the EU has adopted several regulations aimed at tackling future public health emergencies, namely:

  • Regulation (EU) 2022/123 on a reinforced role for the European Medicines Agency (“EMA”) in crisis preparedness and management for medicinal products and medical devices (“Regulation 2022/123”).
  • Regulation (EU) 2022/2371 on serious cross-border threats to health (“Regulation 2022/2371”).
  • Council Regulation (EU) 2022/2372 on a framework of measures for ensuring the supply of crisis-relevant medical countermeasures in the event of a public health emergency at Union level (“Regulation 2022/2372”).

The Commission has also published a proposal for a Regulation on compulsory licensing for crisis management, which is currently going through the EU legislative procedure.  The Commission proposal for a Single Market Emergency Instrument, which does not relate specifically to health but indirectly impacts medical devices, is also going through the EU legislative process (see our blog on this topic here).

Impact of each Regulation on Medical Devices

a. Regulation on Reinforced Role for EMA

Regulation 2022/123 provides a framework for managing the impact of public health emergencies and major events, and assigns new tasks to the EMA, including monitoring, preventing and reporting shortages of medicines and medical devices.  The Regulation became applicable on 1 March 2022 for medicines and on 2 February 2023 for shortages of critical medical devices.  In respect of the latter, the Regulation established within the EMA the Executive Steering Group on Shortages of Medical Devices (“MDSSG”) to coordinate urgent actions within the Union in relation to the management of supply of critical medical devices and in vitro diagnostic medical devices in the case of a public health emergency. 

Following the recognition of a public health emergency, Regulation 2022/123 sets out certain measures that will impact medical devices:

  • The MDSSG must adopt and publish a list of categories of medical devices which it considers to be critical during the public health emergency.  MDSSG will gather information on those medical devices through EUDAMED, but also directly from importers, distributors, and national databases.
  • The MDSSG must then monitor supply and demand with a view to identifying shortages of critical medical devices. 
  • The MDSSG must also regularly report the information it gathers under the previous two points to the Commission and to Member States and make recommendations on approach to manage (potential) shortages of critical devices.
  • To facilitate the information collection detailed above, the EMA may request information from manufacturers of critical medical devices, authorised representatives, importers, distributors, and notified bodies.  Relevant economic operators will also have an obligation to proactively report information on shortages to the EMA.
  • The Commission, taking into account the MDSSG’s recommendations, must take all necessary action with a view to mitigating actual or potential shortages of medical devices included on the public health emergency critical devices list.  The Commission will be empowered to do this in a number of ways, including through adopting guidelines for Member States and liaising with third countries and international organizations.

b. Regulation on Serious Cross-Border Threats to Health

Regulation 2022/2371 entered into force on 26 December 2022.  It lays down rules for the surveillance, preparedness, response planning, and emergency research related to cross-border threats to health.  This Regulation repeals and replaces the previous Decision 1082/2013/EU.  In this framework, it addresses EU-Member States joint procurement for medical countermeasures (including medical devices) and provides that the Commission and Member States may engage, as contracting parties, in a joint procurement procedure. 

The Commission will take a central role in this process and will ensure coordination and exchange of information between parties, compliance with procurement procedures (including in particular the EU Financial Regulation (EU) 2018/1046), and execution of the procurement.  This could include development, stockpiling, distribution, and donation of medical countermeasures.  Importantly, Regulation 2022/2371 also permits the advance purchase of medical countermeasures in anticipation of a potential serious cross-border threat to health.  

c. Regulation on Supply of Crisis-relevant Medical Countermeasures

Regulation 2022/2372 establishes a framework of measures for ensuring the supply of crisis-relevant medical countermeasures (including medical devices) in the event that a public health emergency at Union level has been established.  It creates the Health Crisis Board to coordinate the implementation of measures adopted under the Regulation.

In the event of a public health emergency, Regulation 2022/2372 grants power to the Council to adopt, upon proposal of the Commission, a regulation activating the emergency framework and setting out appropriate measures to handle the situation.  There are five measures that could impact medical devices:

  • Monitoring: the Commission will monitor the supply and demand of crisis-relevant medical countermeasures, including medical devices: their production capacity, stockpiles, possible supply chain disruptions and purchasing agreements.
  • Procurement and manufacturing: the Health Crisis Board will advise the Commission on appropriate ways to procure crisis-relevant countermeasures, including medical devices (e.g., through existing contracts, or through Regulation 2022/2371).  In case of shortage, the Commission has power to help increase the availability of crisis-relevant medical countermeasures. 
  • Inventory of production and production facilities: the Commission may request manufacturers of crisis-relevant countermeasures, including medical devices, to inform on their production capacity and existing stocks, in the EU or in third countries.  The requested information may also include a schedule of production plans for the next three months.
  • Inventory of crisis-relevant medical devices: where it considered that there is a risk of shortage of medical devices, the Commission may request that manufacturers share an inventory of those medical devices.
  • Measures to ensure availability and supply: where it considers that there is a risk of shortage for medical countermeasures, including medical devices, the Commission may adopt measures to increase their availability (i.e., reorganize supply chains and utilise existing stocks).  In doing so, the Commission will have to act in coordination with concerned Member States and economic operators.  Potential measures include: (i) Facilitating the creation, expansion or repurposing of production capacities; (ii) Implementing procurement initiatives, reserving stockpiles; (iii) Facilitating the licensing of intellectual property and know-how.

d. Commission Proposal for a Regulation on Compulsory Licensing for Crisis-management

On 27 April 2023, the Commission proposed to establish a Union compulsory licensing of certain intellectual property rights in force in one or more Member States: patents (including published patent applications), utility models, or supplementary protection certificates. 

According to the proposal, the Commission may grant a Union compulsory license if an emergency or crisis instrument has been activated (e.g., if a public health emergency is recognized under Regulation 2022/2371, or where the emergency framework under Regulation 2022/2372 is activated).  If granted, the Union compulsory license would be limited to “crisis-relevant products” which could include medical devices.

The proposal is going through the legislative procedure.  On 13 March 2024, the European Parliament adopted a series of amendments (accessible here).  The Council has not yet adopted its position.

Conclusion

Regulations adopted in the wake of the COVID-19 pandemic create a complex public health crisis management system.  For medical devices, the primary aim of these Regulations is to ensure their availability and supply in times of crises.  To that end, new powers have been granted to the Commission, and new bodies have been created to monitor and oversee issues that could impact the supply of medical devices and in vitro diagnostic medical devices to the EU market. 

Measures that may be adopted under this new coordinated system could potentially be far-reaching.  They include supply chain monitoring, information requests, and sometimes direct intervention of authorities in production and distribution of medical devices.  It is difficult to predict how it will work in practice because its implementation has not yet been tested. 

Nevertheless, a possible future activation of this public health crisis management system is very likely to impact medical devices.  To anticipate measures under these Regulations, it will be important for companies to pay attention to the work of the Commission and newly created bodies as they monitor the market and report on its situation.

It is in any event reassuring to know that European institutions and regulatory agencies are committed to implementing a coordinated approach to manage shortages of critical products in the event of future pandemics or health emergencies. 

If you have any queries concerning the material discussed in this blog or medical devices more broadly, please contact members of our Food, Drug, and Device practice.

Photo of Sarah Cowlishaw Sarah Cowlishaw

Advising clients on a broad range of life sciences matters, Sarah Cowlishaw supports innovative pharmaceutical, biotech, medical device, diagnostic and software technology companies on regulatory, compliance, transactional, and legislative matters.

Sarah has particular expertise in advising on legal issues presented by digital health…

Advising clients on a broad range of life sciences matters, Sarah Cowlishaw supports innovative pharmaceutical, biotech, medical device, diagnostic and software technology companies on regulatory, compliance, transactional, and legislative matters.

Sarah has particular expertise in advising on legal issues presented by digital health technologies, helping companies navigate regulatory frameworks while balancing challenges presented by the pace of technological change over legislative developments.

Sarah is a co-chair of Covington’s multidisciplinary Digital Health Initiative, and is the Graduate Recruitment Partner for Covington’s London office.

Sarah regularly advises on:

  • classification determinations for software medical devices, including on developments resulting from the implementation of the EU Medical Devices Regulation;
  • legal issues presented by digital health technologies including artificial intelligence;
  • general regulatory matters for the pharma and device industry, including borderline determinations, adverse event and other reporting obligations, manufacturing controls, and labeling and promotion;
  • the full range of agreements that span the product life-cycle in the life sciences sector, including collaborations and other strategic agreements, clinical trial agreements, and manufacturing and supply agreements; and
  • regulatory and commercial due diligence for life sciences transactions.

Sarah’s pro bono work includes advising the Restoration of Appearance and Function Trust (RAFT) on the classification of a wound healing product containing human blood derivatives, and assisting in a project aimed at improving regulatory systems for clinical trials of drugs and vaccines for neglected diseases in developing countries.

Sarah has been recognized as one of the UK’s Rising Stars by Law.com (2021), which lists 25 up and coming female lawyers in the UK. She was named among the Hot 100 by The Lawyer (2020) and was included in the 50 Movers & Shakers in BioBusiness 2019 for advancing legal thinking for digital health.

Sarah has undertaken several client secondments, including to the in-house legal department of a multinational pharmaceutical company.

Photo of Lucas Michel Lucas Michel

Lucas is an associate in the Life Sciences practice.

He advises clients across a wide range of regulatory, compliance and procedural issues in the food, pharma, and medical devices sectors, with a focus on EU and Belgian regulatory advice.

Lucas also assists clients…

Lucas is an associate in the Life Sciences practice.

He advises clients across a wide range of regulatory, compliance and procedural issues in the food, pharma, and medical devices sectors, with a focus on EU and Belgian regulatory advice.

Lucas also assists clients on public procurement matters, ESG queries, and represents clients in Belgian and EU courts.

Zoé Bertrand

Zoé Bertrand is an associate in the Life Sciences Practice group. Zoé advises clients across a wide range of regulatory and compliance issues in the pharmaceutical, food, and cosmetics sectors, with a focus on EU, Belgian, and French regulatory advice. She is a…

Zoé Bertrand is an associate in the Life Sciences Practice group. Zoé advises clients across a wide range of regulatory and compliance issues in the pharmaceutical, food, and cosmetics sectors, with a focus on EU, Belgian, and French regulatory advice. She is a native French speaker and fluent in English.