April, 3 2020
Postponement of application of the Medical Devices Regulation
On 3 April, the European Commission adopted a proposal aiming at postponing by one year (26 May 2021) the date of application of the Medical Devices Regulation. This is aimed at allowing Member States, health institutions and economic operators to prioritise the fight against the COVID-19 crisis and at ensuring that Member States and the Commission can address potential shortages of vitally important medical devices in the EU in a more effective manner through EU wide derogations.
The Commission proposes that the European Parliament and the Council adopt the proposal through an accelerated co-decision procedure.
- Postponement of COP 26
On 1 April, following the announcement by the UK Presidency that the COP26 will be postponed (as part of the fight against the COVID-19), the European Commission informed that it will not slow down its work (be it domestically or internationally) to prepare for an ambitious COP26, when it takes place. It confirmed that it will present by September 2020 an impact assessment plan to raise the EU's 2030 ambitions and cut greenhouse gas emissions by 50-55% compared to 1990 levels. It will also continue its work to submit an enhanced Nationally Determined Contribution to the United Nations Framework Convention on Climate Change (UNFCCC) in line with the EU’s commitment under the Paris Agreement. Finally, the Commission will continue to work at international level to encourage its partners to raise their ambitions as regards realising the Paris Agreement targets.
- Second COVID-19 Response (Coronavirus Response Investment Initiative Plus (CRII+)
On 2 April, the European Commission presented its second package of measures answering the COVID-19 crisis - CRII+. The elements of this package are:
- A proposal to create a new EU solidarity instrument, SURE, to assist Member States to address sudden increases in public expenditure to preserve employment. SURE will provide financial assistance up to €100 billion in EU loans and will be an EU-wide scheme helping Member States to cover the costs directly related to the creation or extension of national short-time work schemes, and other similar measures they have put in place for the self-employed as a response to the COVID-19 crisis
- A proposal to provide maximum flexibility to allow Member States to use the European Structural and Investment Funds to cope with the crisis: this flexibility means: no limit on transfers between funds or between regions, no limits on spending per policy objective, no requirements on co-financing.
- A proposal to set up the EU Emergency Support Instrument for the healthcare sector, a new EU solidarity instrument granted with €3 billion from the EU budget, in order to
- directly purchase or procure emergency support on behalf of Member States and distributing medical supplies such as masks and respirators;
- financially support and co-ordinate pressing needs such as the transportation of medical equipment and of patients in cross-border regions;
- support the construction of mobile field hospitals.
To generate economies of scale wherever possible, the Commission will directly procure on behalf of Member States and focus the help where the needs are.
- Other initiatives include a proposal to adapt the Fund for European Aid to the Most Deprived and specific measures to support Europe’s fishermen and farmers.
More information is available as follows:
- Questions and answers on the Coronavirus Response Investment Initiative Plus: New actions to mobilise essential investments and resources
- Questions and answers: Commission proposes SURE, a new temporary instrument worth up to €100 billion to help protect jobs and people in work
- European Union Emergency Support Instrument for the healthcare sector - questions and answers
- Public Procurement
On 1 April, the European Commission published a guidance documentrelated to the use of all the flexibilities offered by the EU public procurement framework in the emergency situation caused by the coronavirus outbreak. It provides an overview of the choice of tendering procedures available to public buyers and applicable deadlines, points out possibilities (considerable shortening of the generally applicable deadlines, procuring without prior publication of tender notices in exceptional circumstances, etc…) and provides clarification on how in situations of scarcity of key supplies public buyers could find alternative solutions and ways of engaging with the market.
- Personal Protective Equipment
The European Commission has published two documents related to the export of Personal Protective Equipment
- A list of the competent authorities in Member States in charge of export authorisation scheme for personal protective equipment
- A set of Frequently Asked Questions on Export requirements for personal protective equipment
The European Competition Network, consisting of the European Commission, the EFTA Surveillance Authority and the National Competition Authorities has issued a joint statement on the application of the antitrust rules during the current coronavirus crisis, explaining how competition authorities can help companies handle specific cooperation agreements in the time of the COVID-19 crisis.
Moreover, the European Commission DG Competition has set up the following dedicated mailbox COMP-COVID-ANTITRUSTnoSpam@ec.europa.eu, that can be used by companies, industry associations or their legal advisers to seek informal guidance on the compatibility with EU competition rules of specific cooperation initiatives with an EU dimension that specifically address the crisis
For local or national cooperation agreements (without an EU dimension), DG Competition recommends that companies, associations or their legal advisers contact directly the competent National Competition Authority.
Guidance documents on product compliance
On 31 March, the Commission issued three guidance documents to assist manufacturers in ramping up production of essential medical equipment and material in three areas the production of masks and other personal protective equipment(PPE), leave-on hand cleaners and hand disinfectants and 3D printing in the context of the coronavirus outbreak.. These documents offer practical advice on the application of the Commission's recommendation on conformity assessments of protective personal equipment (PPE), and certain types of medical devices, issued on 13 March.
On 30 March, the European Commission issued a guidance document on the implementation of the temporary restriction on non-essential travel to the EU. Together with the other document on free movement of critical workers, it helps facilitating transit arrangements for repatriated citizens by assisting border guards and visa authorities, providing advice on the implementation of the temporary restriction at the border, on facilitating transit arrangements for the repatriation of EU citizens, and on visa issues. Detailed practical guidance is provided for border authorities on key issues, such as: criteria for refusing entry, exemptions, security, exit checks, transit and repatriation, or visa applications and overstay.
Within these guidelines the Commission outlines a series of measures addressing the free movement of frontier workers, posted workers and temporary workers providing essential services.
The main elements of the guidelines can be found summarised below:
- Essential services are defined within the guidelines. In addition to medical professionals and transport drivers, of key relevance for our sectors would be: ICT professionals including technicians responsible for the operation and maintenance of equipment, engineering professionals such as energy or electrical technicians, people working on critical or essential infrastructure and science and engineering associate professionals. The full list can be found on page 3 of the guidelines.
- Member States should establish burden-free and fast-crossing procedures in borders with regular flows of frontier or posted workers. The Commission will consult the Technical Committee on the Free Movement of Workers to identify best practices.
- Health screenings:
- The same screenings should be applied than for national workers
- Health screenings may be carried out before or after the border, and Member States should coordinate amongst themselves to avoid additional bottlenecks. Furthermore, the screening should be based on temperature checks. If a worker is identified as having a fever he/she must be afforded the same care as workers from the country of employment; and the Member State should notify the neighbouring Member State of concern.
- The health screenings for transport workers will follow the guides in the “Communication on the implementation of the Green Lanes”
- Frontier and posted workers should be allowed to continue cross the border if their activities are still allowed in the host Member State
- In situations where there could be a change in the Member State of insurance of the worker, Member States can request an exception to maintain the insurance of the worker unchanged. It is the responsibility of the employer to apply for this exception to the Member State to which the worker requests to be covered by its’ legislation.
Europe’s technology industries call to maintain industrial production and related operations wherever possible
The COVID-19 outbreak represents an unprecedented situation for Europe’s citizens, society and economy. In these difficult times focus is needed on the crucial role of Europe’s industry to support society’s needs. This is why we are calling for an unequivocal commitment by the EU’s leaders that, wherever possible, industrial production and related operations must be maintained throughout the COVID-19 crisis. Read our statement here.