Commissioner Kyriakides welcomes Council vote on the Medical Device Regulation extension


Today, the Council of the European Union has adopted the Commission’s proposal to give notified bodies and manufacturers more time to certify medical devices and thereby mitigate the risk of shortages. This follows the positive vote by the European Parliament last month. The legislative proposal provides a longer transition period to adapt to new rules foreseen under the Medical Devices Regulation, ensuring continued access to medical devices for patients in need.

Welcoming the adoption by the Council, Commissioner for Health and Food Safety, Stella Kyriakides, said

‘I would like to express my gratitude to the European Parliament, the Council, and the Swedish Presidency in particular for swiftly agreeing on our proposal to extend the transitional periods of the Medical Devices Regulation. This is an important step that will help address the short-term difficulties Member States are facing and ensure a continued access to needed medical devices for patients in the EU.

This revised timeline will provide more flexibility to industry for the ongoing certification of needed medical devices and reduce short-term risks of shortages. This will ensure access for patients most in need without jeopardising their safety. It is important to recall that only devices that are safe and for which manufacturers have already taken steps to transition to the Medical Devices Regulation can benefit from this additional time. Patient safety will always be paramount.

The Commission, together with Member States, notified bodies and the medical industry will continue to work on additional measures to address the structural problems and identify medium and long-term solutions. Ensuring the transition to the new Regulations must be our collective priority to safeguard patient safety and foster innovation in Europe.’

Next steps

Following today’s adoption by the Council, the proposed amendment to the Medical Devices Regulation is expected to be formally adopted by both the European Parliament and the Council on 15 March 2023. Shortly after, it will be published in the Official Journal and enter into force on the day of its publication.

The Commission will work together with Member States and all stakeholders to provide the necessary support to implement this legislative amendment.


The Medical Devices Regulation has been applicable since 26 May 2021. It provides for a transition period until 26 May 2024. The transition to the new Regulation has been slower than anticipated and healthcare systems in the EU are facing a risk of shortages.

At the EPSCO Council on 9 December 2022, EU Health Ministers called on the Commission to swiftly submit a proposal to extend the transition period in the Medical Devices Regulation. The Commission submitted a proposal on 6 January 2023, which was negotiated by the European Parliament and the Council in an urgency procedure.

For More Information

Proposal for a Regulation amending Regulation 2017745

Factsheet on the European Health Union Supporting the transition to the new medical device framework

Questions and Answers

Medical devices – new Regulations

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Council vote on the Medical Device Regulation extension

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+32 2 298 46 80


• Célia DEJOND


+32 2 298 81 99


Security Union The renewed Schengen Information Systems enters into operation

Today, the upgraded Schengen Information System (SIS) enters into operation. SIS is the largest information sharing system for security and border management in Europe. It provides information on wanted or missing persons, third-country nationals with no legal right to stay in the Union and lost or stolen objects (for example cars, firearms, boats and identity documents).

The renewed SIS is the foundation of the most advanced border management system in the world that we are building. Together with the EntryExit System (EES) and the European Travel Information and Authorisation System (ETIAS), SIS will be part of the interoperability architecture.

The renewed SIS is being enhanced to include new categories of alerts, biometrics such as palm prints, fingermarks, and DNA records for missing persons, and additional tools to combat crime and terrorism. The upgrade is important as it will also allow for preventive alerts to protect vulnerable persons and deter irregular migration. These upgrades aim to provide national authorities with more complete and reliable information to enhance security and border management in Europe.

The upgraded features include

Enhanced information sharing and cooperation New categories of alerts and more data will be shared through SIS, ensuring that more complete and more reliable information is available to the national authorities. Clearer rules and improved structures have been introduced for the exchange of information through the national contact points (SIRENE Offices).

New possibilities to locate and identify persons sought and strengthen external border controls In addition to photographs and fingerprints, SIS will contain new types of biometrics (such as palm prints, fingermarks and palmmarks, as well as DNA records – but only in relation to missing persons) and other information to locate and identify people registered in the system.

Additional tools to combat criminality and terrorism New inquiry check alerts will allow national authorities to collect targeted information on suspects of serious crime or terrorism. For example, identification documents, information about the car that they are using will be stored in SIS. There will be alerts on ‘unknown wanted persons’, containing only the prints of unknown perpetrators that are discovered at the scenes of terrorist offences or serious crimes.

Additional tools to protect missing and vulnerable persons National authorities will be able to issue preventive alerts in the system to protect certain categories of vulnerable persons (children at risk of abduction or potential victims of terrorism, trafficking in human beings, gender-based violence, or armed conflicthostilities), in addition to existing alerts on missing persons.

Additional tools to prevent and deter irregular migration Return decisions will be part of the information shared in the system to improve the effective enforcement of these decisions. Member States will be required to create an alert in SIS each time they issue a return decision on a third-country national with no legal right to stay in the EU, allowing them to actively follow up whether the returnee effectively leaves the EU territory. It will pave the way for mutual recognition of return decisions between Member States, as proposed by President von der Leyen in her letter with targeted actions ahead of the February European Council.

Enhanced use of SIS by EU Agencies Europol and national immigration authorities now have access to all alert categories in SIS. The European Border and Coast Guard Agency (Frontex) operational teams have been granted access to SIS (implementation is still ongoing).

SIS has strict requirements on data quality and data protection. The system only contains data on people and objects wanted in EU countries and Schengen associated countries. National authorities supervise the application of the data protection rules in their respective countries, while the European Data Protection Supervisor (EDPS) monitors how the data protection rules are being applied in the central system managed by eu-LISA.

Next Steps

As of today, the renewed SIS is operational in 30 countries throughout Europe (26 EU Member States and the Schengen associated countries). The connection of Cyprus to SIS in summer 2023 will further extend security cooperation throughout the entire Union.


SIS was created in 1995 following the abolition of internal border controls in the EU. The 2016 evaluation of SIS confirmed the outstanding success of the system. But it also identified opportunities to further enhance the effectiveness and efficiency of SIS, to better tackle increasingly complex security challenges.

The Commission tabled three proposals to strengthen cooperation between the Member States making use of the Schengen Information System (SIS) on 21 December 2016. On 12 June 2018, the co-legislators, the European Parliament and the Council reached political agreement on all three proposals. The three agreed Regulations (available here, here and here) were adopted on 28 November 2018.

The legal and technical preparations for the implementation of the new SIS started in 2019 and continued until 2021. During 2022, the national and central systems were thoroughly checked in close cooperation between eu-LISA (the EU agency in charge of the operation of the central competent of SIS) and the Member States (in charge of the national components of SIS). The legal conditions for the start of operation were completed in January 2023 and on 31 January 2023, the decision of the start of operation was published by the Commission.

For More Information


DG HOME website – Schengen Information System

eu-LISA – European Union Agency for the Operational Management of Large-Scale IT Systems in the Area of Freedom, Security and Justice

Press Release – Security Union Commission proposes to reinforce the Schengen Information System to better fight terrorism and cross-border crime

Press Release – Security Union Commission welcomes agreement on a reinforced Schengen Information System


The start of operation of the renewed SIS marks a clear step forward in the management of our external borders and our common Schengen Area. It is a key milestone in making Europe a safer place for its citizens.

Ylva Johansson, Commissioner for Home Affairs – 07032023

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The renewed Schengen Information Systems

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• Anitta HIPPER


+32 2 298 56 91


• Fiorella BELCIU


+32 2 299 37 34


• Andrea MASINI


+32 2 299 15 19


EU-UN cooperation EU announces support to the UN reform for more efficiency in partner countries

Today, at the UN Conference on Least developed countries (LDCs) in Doha, the EU announced its renewed support to the UN Resident Coordinator System, a key pillar of the UN development system reform, with a contribution of pound 17 million for 2022 and 2023. The UN Resident Coordinator System aims to improve the efficiency and effectiveness of UN actions at country level through dedicated UN Resident Coordinators. They act as key interlocutor for partners and international donors, including the EU, thus ensuring more effective and efficient coordination.

Commissioner for International Partnerships, Jutta Urpilainen, said ‘The EU is a steadfast supporter of the UN Development reform. In this time of multiple global challenges, the most effective way to deliver results on the ground for the LDCs and our other partners is multilateral cooperation and coordination. We champion renewed and more effective multilateralism.’

The EU’s support will benefit the cooperation and dialogue between the EU and UN when building programmes with and in partner countries, in the framework of the EU’s Global Gateway strategy, and in line with the Sustainable Development Goals. Better coordination and dialogue between the EU and the UN also enables to show to third country partners the strength of a coordinated and democratic offer.

The present contribution confirms the EU’s longstanding support to the UN reform process, expressed both politically and financially through contributions to the UN Residents Coordinator System and the UN Joint SDG Fund with a total of pound 74 million since 2019.

More information is available in the web release here.

(For more information Ana Pisonero Hernandez – Tel. +32 2 295 43 20; Jennifer Sanchez Da Silva – Tel. +32 2 295 83 16)

European Education Area 16 new Erasmus+ Teacher Academies will promote excellence in teacher education

Today, the Commission presents 16 new Erasmus+ Teacher Academies, which will provide teachers at all stages of their careers with learning opportunities that include mobility, learning platforms and professional communities. These Erasmus+ Teacher Academies will benefit from close to pound 22.5 million from the Erasmus+ budget over three years. The 16 new Academies, together with the 11 already funded under the first call for proposals last year, will embrace multilingualism, language awareness and cultural diversity, as they develop teacher education in line with the EU’s priorities in education policy and contribute to the achievement of the European Education Area, the EU’s vision for the education and training sector.

Vice-President for Promoting our European Way of Life, Margaritis Schinas said ‘A teacher who keeps learning will pass on the newly acquired knowledge to hisher students. With the new learning opportunities we are providing today, we are enriching both teachers and learners; yet another concrete step towards the European Education Area.’

At the Education, Youth, Culture and Sport Council this morning, the Commissioner for Innovation, Research, Culture, Education and Youth, Mariya Gabriel, said ‘The shortage of teachers is an EU-wide challenge to be addressed at EU level. Therefore, we are putting in place comprehensive initiatives to make the profession more attractive. Erasmus+ Teacher Academies will support our efforts to ensure high-quality initial education and continuous professional development for all teachers, educators and school leaders. We had set ourselves the goal of establishing 25 such academies by 2025. Today, we are already at 27. The success speaks for itself!’

Erasmus+ Teacher Academies are partnerships between teacher training providers and teacher education institutions that will develop a European and international outlook in teacher education. The topics covered by the projects include skills related to science, technology, engineering, arts and mathematics, creativity, inclusion, and environmental sustainability. As part of the 2022 call for proposals, the selected projects include 313 organisations, as well as 136 associated partners, from 30 countries (EU Member States and countries associated to Erasmus+). Among the participating organisations there are initial teacher education providers, continuing professional development providers, practice training schools, and other organisations with relevant expertise. More information is available online.

(For more information Sonya Gospodinova – Tel. +32 2 296 69 53; Federica Miccoli – Tel. +32 2 295 83 00)

Agriculture Record value of EU agri-food trade in November 2022

The Commission has today published the latest monthly agri-food trade report, which shows that the monthly EU trade flows of agricultural and food products reached a new record value of pound 36.9 billion in November 2022. Since the beginning of 2022, EU agri-food trade reached a total of pound 369 billion, which represents a 23% increase compared to the same period in 2021 (Jan-Nov). This can be explained by an increase of the value of both EU agri-food exports and imports, by 17% and 34% respectively. In the same period, the EU trade balance stands at pound 53.5 billion.

Compared to October 2022, EU agri-food exports slightly increased compared to the previous month, to reach pound 21.2 billion, a 2% increase. From January to November 2022, EU agri-food exports reached pound 211 billion. When looking at specific sectors, the data confirm the higher EU exports of wheat from January to November 2022. The two main destinations for EU products are the United Kingdom and the United States. EU exports of pigmeat, cereals and vegetable oils to China decreased in the same period, while EU exports to Russia declined significantly both in quantity and value terms for a range of sectors.

EU imports of agriculture and food products remained quite stable in November 2022 compared with the previous month. However, due to higher food prices on the global markets, the value of EU imports increased and reached pound 157 billion in the 11 months of 2022. The three main origin countries exporting agri-food products to the EU are Brazil, the UK and Ukraine. The biggest increases over the year 2022 were recorded for imports of primary commodities, such as maize (+9 million tonnes), soya cake (+737 thousand tonnes), and rapeseed (+1.3 million tonnes).

The latest monthly agri-food trade report also features a special focus on the evolution of production and consumption of poultry and beef from 1961 to 2019 across Europe, Central Asia, Asia-Oceania, Africa and the Americas.

More insights as well as detailed tables are available in a news item online.

(For more information Miriam Garcia Ferrer – Tel. +32 2 299 90 75; Thérèse Lerebours – Tel. +32 2 296 33 03)

International Women’s Day EU takes landmark decisions, but women’s rights are under attack globally

Ahead of International Women’s Day, the European Commission and the High Representative of the Union for Foreign Affairs and Security Policy made the following statement

‘The growing oppression globally on women and girls and attacks on their human rights are alarming. We stand by women in Iran, whose freedoms are systematically restricted; and those in Afghanistan, where the Taliban are trying to erase women and girls’ presence from public space, as well as everywhere else in the world where women’s fundamental rights and freedoms are being threatened or denied.

We are also deeply concerned about the reports that Russian Armed Forces use sexual violence against women and children in Ukraine as a weapon of war. These actions constitute war crimes and the perpetrators must be brought to justice. We will continue to work with our international partners to make Russia pay for these atrocities.

To strengthen global accountability, the EU has just adopted a package of sanctions against perpetrators of sexual and gender-based violence.

There is also good news. The EU has taken landmark decisions to ensure that women in the EU have the same opportunities as men. For instance, with the new EU rules on gender balance on corporate boards or pay transparency. We also want to set EU-wide rules to combat violence against women and domestic violence.’

The full statement is available online.

(For more information Christian Wigand – Tel. +32 2 296 22 53; Katarzyna Kolanko – Tel. +32 2 296 34 44)


Wednesday 8 March

Mr Margaritis Schinas receives students from the Diplomatic Academy of Greece; delivers a keynote speech at the Masters of Digital 2023.

Thursday 9 March 3

Mr Margaritis Schinas co-chairs the EPP Ministers of Interior meeting.

Ms Stella Kyriakides in Nicosia, Cyprus (until 1003) delivers an opening speech on the role of women in sport at an Event organised by the Cyprus Olympic Committee.

Friday 10 March

Ms Stella Kyriakides in Nicosia, Cyprus meets with Mr Nikos Christodoulides, President of the Republic of Cyprus; meets with Mr Konstantinos Kompos, Minister of Foreign Affairs of Cyprus; meets with Ms Popi Kanari, Health Minister of Cyprus; meets with Mr Petros Xenofontos, Agriculture, Rural Development and Environment Minister of Cyprus.

The European Commission is committed to personal data protection. Any personal data is processed in line with Regulation (EC) 20181725. All personal information processed by the Directorate-General for Communication European Commission Representations is treated accordingly.

Source Cyprus News Agency