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Today, the European Commission has adopted a proposal to postpone by one year the date of application of the Medical Devices Regulation to allow Member States, health institutions and economic operators to prioritise the fight against the coronavirus pandemic. This decision takes into account the unprecedented challenges of the coronavirus pandemic and the need for an increased availability of vitally important medical devices across the EU whilst continuing to ensure patient health and safety until the new legislation becomes applicable. Vice-President for Promoting our European Way of Life, Margaritis Schinas, said: “Shortages or delays in getting key medical devices certified and on the market are not an option right now. The Commission is therefore taking a pragmatic approach and delaying the entry into application of new EU rules on medical devices, so we can have our medical industries pouring all their energy into what we need them to be doing: helping fight the pandemic. This shows once again that the European Union is leaving no stone unturned in our support to national public health systems in their hour of need.” Stella Kyriakides, Commissioner for Health and Food Safety, said: “Our priority is to support Member States to address the coronavirus crisis and protect public health as powerfully as possible – by all means necessary. Any potential market disruptions regarding the availability of safe and essential medical devices must and will be avoided. Today's decision is a necessary measure in these very exceptional times.” As the coronavirus crisis increases demands for certain vital medical devices, it is crucial to avoid any further difficulties or risks of potential shortages or delays in the availability of such devices caused by capacity limitations of authorities or conformity assessment bodies related to the implementation of the Medical Devices Regulation. Today's proposal therefore postpones, for exceptional reasons in the current context, the application of the Regulation by one year - until 26 May 2021. Whilst the new Medical Devices Regulation is key to ensure patient safety and increase transparency on medical devices across the EU, the currently applicable rules will continue to guarantee the protection of public health. In addition, the proposal also ensures 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 proposal would need the full support of the European Parliament and the Council through an accelerated co-decision procedure. Background The coronavirus pandemic and the associated public health crisis presents an unprecedented challenge to Member States and is a high burden for national authorities, health institutions and economic operators. The coronavirus crisis has created extraordinary circumstances that require substantial additional resources and an increased availability of vitally important medical devices. None of this could reasonably have been anticipated at the time of adoption of the Medical Devices Regulation. Those extraordinary circumstances have a significant impact on various areas covered by the Medical Devices Regulation. It is therefore very likely that Member States, health institutions, economic operators and other relevant parties would not have been in a position to ensure its proper implementation and application from the stipulated date of application on 26 May 2020. To safeguard an effective regulatory framework for medical devices, it is also necessary to postpone the date of repeal of the Directive on active implantable medical devices and the Directive on medical devices by one year. This proposal will not affect the date of application of the In Vitro Diagnostics Medical Devices Regulation, which becomes applicable from 26 May 2022.

Today, the European Commission has published guidance on the development of new apps that support the fight against coronavirus in relation to data protection. The development of such apps and their take up by citizens can have a significant impact on the treatment of the virus and can play an important role in the strategy to lift containment measures, complementing other measures like increased testing capacities. It is important, however, to ensure that EU citizens can fully trust such innovative digital solutions and can embrace them without fear. The largest possible participation of EU citizens is necessary to exploit the full potential of tracing apps. EU rules, notably the General Data Protection Regulation (GDPR) and the ePrivacy Directive, provide the strongest safeguards of trustworthiness (i.e. voluntary approach, data minimisation, time limitation) for such apps to operate widely and accurately. This guidance aims to offer the necessary framework to guarantee that citizens have sufficient protection of their personal data and limitation of intrusiveness while using such apps. The European Data Protection Board was consulted on the draft guidance. By committing to those standards, the full effectiveness and compliance of such tools can be ensured, even in times of crisis. Vice-President for Values and Transparency, Věra Jourová, said:”This is the first global crisis where we can deploy the full power of technology to offer efficient solutions and support the exit strategies from the pandemic. Trust of Europeans will be key to success of the tracing mobile apps. Respecting the EU data protection rules will help ensure that our privacy and fundamental rights will be upheld and that the European approach will be transparent and proportional.” Commissioner for Justice, Didier Reynders, said: “The use of mobile phone apps have the potential to really help in the fight against coronavirus, for example by helping users to diagnose themselves, as a safe communication channel between doctors and patients, by alerting users who are at risk of catching the virus, and to help us lift confinement measures. At the same time, we are talking about very sensitive data being collected on the health of our citizens, which we are duty-bound to protect. Our guidance supports the safe development of apps and protect our citizens' personal data, in line with the EU's strong data protection rules. We will get out of the sanitary crisis, while keeping our fundamental rights intact.

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The College adopted a proposal which will further reinforce the EU’s tax transparency framework and discussed the preparation of the June European Council. New transparency rules for tax planning intermediaries Recent events such as the Panama Papers revelations have exposed how some intermediaries actively assist companies and individuals to escape taxation, usually through complex cross-border schemes. This is the reason why the European Commission has today proposed tough new transparency rules for intermediaries – such as tax advisors, accountants, banks and lawyers – who design and promote tax planning schemes for their clients. This initiative is part of the Juncker Commission's far-reaching agenda to increase tax transparency and tackle tax avoidance and tax evasion. The proposal aims to curb such aggressive tax planning by increasing scrutiny around the previously-unseen activities of tax planners and advisers. Cross-border tax planning schemes bearing certain characteristics which can result in losses for governments will now have to be automatically reported to the tax authorities before they are used. The Commission has identified key issues, including the use of losses to reduce tax liability, the use of special beneficial tax regimes, or arrangements through countries that do not meet international good governance standards. The new rules are comprehensive, covering all intermediaries, all potentially harmful schemes and all Member States. Preparation of European Council The College prepared the June European Council (22-23 June). EU leaders will discuss a range of topics including migration, the economy, security and defence, climate change and Digital Europe. The Commission's contribution includes, among others, four progress reports on measures taken under the European Agenda on Migration to stabilise the flows and better manage the external borders but also concrete proposals at European level to improve the security of citizens. At 27, EU leaders will also discuss and decide on the procedure and the criteria for the relocation of two EU agencies from London (the European Medicines Agency and the European Banking Authority). Death of former German Chancellor Helmut Kohl At the College meeting President Juncker paid tribute to former German Chancellor Helmut Kohl: "We have lost a great man, a true friend, and the Chancellor of German reunification," President Juncker said. To honour the legacy of Dr. Helmut Kohl, Honorary Citizen of Europe, the three European institutions are co-organising a European Ceremony of Honour on 1 July in the European Parliament in Strasbourg. This will be followed by a ceremonial event in the cathedral in Speyer (Germany). Future of EU finances by 2025 The College also held an orientation debate on the future of EU finances by 2025. Commissioners Oettinger and Crețu introduced the debate and outlined the key issues to be tackled, including the timing of the Commission's proposals on the next Multiannual Financial Framework. Solidarity with Italy The Commission proposed to mobilise €1.2 billion under the EU Solidarity Fund, the highest sum ever mobilised in a single instalment, following the earthquakes of 2016 and 2017 in the Italian regions of Abruzzo, Lazio, Marche and Umbria. From day one, the Commission provided support to address the immediate emergency situation and committed to stand side by side with Italy and its people throughout the entire reconstruction process. Today’s proposal is yet another concrete delivery on this promise. [From European Commission]