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Offentliggjort den 29-03-2017

Medical devices and in vitro diagnostic medical devices

29-03-2017

The current EU approval system for medical devices (MDs) and in vitro diagnostic medical devices (IVDs) is based on conformity assessment by 'notified bodies'. A number of scandals stressed the need to tighten the regulatory framework for such devices. The European Commission's proposals for regulations on MDs and IVDs, being discussed in parallel, are extensive and will repeal all existing rules. Votes in Parliament at second reading are expected during the April I plenary.

The current EU approval system for medical devices (MDs) and in vitro diagnostic medical devices (IVDs) is based on conformity assessment by 'notified bodies'. A number of scandals stressed the need to tighten the regulatory framework for such devices. The European Commission's proposals for regulations on MDs and IVDs, being discussed in parallel, are extensive and will repeal all existing rules. Votes in Parliament at second reading are expected during the April I plenary.

EU external action: Refugees and migrants

29-03-2017

An unprecedented mass movement of asylum-seekers and migrants of all ages to the EU started in 2014, reached a peak in 2015 and then continued in 2016 and into 2017. A coordinated and effective protective response is essential, and that needs both a gender and child-sensitive dimension. The European Parliament is expected to vote on a motion for a resolution on 'Addressing refugee and migrant movements: the role of EU External Action' during the April I plenary session.

An unprecedented mass movement of asylum-seekers and migrants of all ages to the EU started in 2014, reached a peak in 2015 and then continued in 2016 and into 2017. A coordinated and effective protective response is essential, and that needs both a gender and child-sensitive dimension. The European Parliament is expected to vote on a motion for a resolution on 'Addressing refugee and migrant movements: the role of EU External Action' during the April I plenary session.

Prospectuses for investors

29-03-2017

Prospectuses are legally required documents presenting the information necessary to enable investors to make an informed assessment of the situation of an issuer and of the rights attached to the securities issued. The EU's co-legislators have reached an agreement on the draft regulation to replace the current directive. This compromise is scheduled for a vote at the April I plenary session.

Prospectuses are legally required documents presenting the information necessary to enable investors to make an informed assessment of the situation of an issuer and of the rights attached to the securities issued. The EU's co-legislators have reached an agreement on the draft regulation to replace the current directive. This compromise is scheduled for a vote at the April I plenary session.

Defining fishing vessels' characteristics

29-03-2017

One dimension of the EU common fisheries policy consists of managing the European fishing fleet and its overall fishing capacity. Rules on the conservation of fisheries resources may vary depending on the features of fishing vessels. During its April I plenary, the Parliament is expected to vote at first reading on a proposal to recast the rules regarding technical characteristics of fishing vessels.

One dimension of the EU common fisheries policy consists of managing the European fishing fleet and its overall fishing capacity. Rules on the conservation of fisheries resources may vary depending on the features of fishing vessels. During its April I plenary, the Parliament is expected to vote at first reading on a proposal to recast the rules regarding technical characteristics of fishing vessels.

Motor vehicles: Approval and market surveillance

29-03-2017

In 2016, following work in previous years but also in response to the VW case, the European Commission made a proposal to strengthen type-approval and market surveillance for motor vehicles. The European Parliament plenary is expected to vote at first reading on the proposal in April.

In 2016, following work in previous years but also in response to the VW case, the European Commission made a proposal to strengthen type-approval and market surveillance for motor vehicles. The European Parliament plenary is expected to vote at first reading on the proposal in April.

Wholesale roaming markets

29-03-2017

The end of roaming costs within the European Union (EU) – promised at political level for over a decade – is near. Four successive regulations have decreased (but not ended) roaming charges for calls, texts and data by more than 90 %. In 2015, the Council and the European Parliament agreed to abolish roaming charges in the EU from 15 June 2017. A precondition is to have new rules in place for wholesale roaming markets. Parliament is expected to vote on the proposal (following agreement in trilogue ...

The end of roaming costs within the European Union (EU) – promised at political level for over a decade – is near. Four successive regulations have decreased (but not ended) roaming charges for calls, texts and data by more than 90 %. In 2015, the Council and the European Parliament agreed to abolish roaming charges in the EU from 15 June 2017. A precondition is to have new rules in place for wholesale roaming markets. Parliament is expected to vote on the proposal (following agreement in trilogue negotiations) at its April I plenary session.

Women and their roles in rural areas

29-03-2017

The many roles played by women in rural communities help to maintain vibrant rural areas and viable farm businesses. Yet despite their crucial contribution, rural women still face numerous challenges, such as difficulties accessing the labour market, a lack of adequate public services and a weak presence in decision-making forums. The European Parliament is scheduled to vote on an own-initiative report on these issues at its plenary in early April.

The many roles played by women in rural communities help to maintain vibrant rural areas and viable farm businesses. Yet despite their crucial contribution, rural women still face numerous challenges, such as difficulties accessing the labour market, a lack of adequate public services and a weak presence in decision-making forums. The European Parliament is scheduled to vote on an own-initiative report on these issues at its plenary in early April.

Visa liberalisation for Ukraine

29-03-2017

Building on its Visa Liberalisation Dialogues, the European Commission is proposing to waive visa requirements for 45 million Ukrainian citizens. In parallel, the European Union (EU) has revised its visa suspension mechanism, reinforcing safeguards to apply to all visa liberalisation agreements.

Building on its Visa Liberalisation Dialogues, the European Commission is proposing to waive visa requirements for 45 million Ukrainian citizens. In parallel, the European Union (EU) has revised its visa suspension mechanism, reinforcing safeguards to apply to all visa liberalisation agreements.

How the EU Budget Has Developed and Changed in the Last 10 years?

15-02-2017

Since the entry into force of the Financial Perspectives of 2007-2013 one decade ago, the EU’s budget has undergone significant change. In 2009, the Treaty on the Functioning of the European Union (TFEU) agreed at Lisbon came into effect. This significantly modified the powers of the European Union’s institutions. The eruption of the global financial crisis in 2008, followed by the crisis particular to the euro area, led to pressure for austerity in the EU’s Member States and put pressure on the ...

Since the entry into force of the Financial Perspectives of 2007-2013 one decade ago, the EU’s budget has undergone significant change. In 2009, the Treaty on the Functioning of the European Union (TFEU) agreed at Lisbon came into effect. This significantly modified the powers of the European Union’s institutions. The eruption of the global financial crisis in 2008, followed by the crisis particular to the euro area, led to pressure for austerity in the EU’s Member States and put pressure on the EU’s budget itself. This briefing provides a summary of these developments.

Ekstern forfatter

Giacomo Benedetto

Human Rights Provisions in Economic Partnership Agreements in Light of the Expiry of the Cotonou Agreement in 2020

23-03-2017

The study considers the options for suspending obligations under the EU-ACP Economic Partnership Agreements (EPAs) in connection with violations of human rights, democratic principles or the rule of law following the expiry of the Cotonou Agreement in 2020. It outlines the functioning of the human rights clause in the Cotonou Agreement, before considering the possibilities for suspending the EPAs under their own provisions, or for other reasons in international law, such as countermeasures. Next, ...

The study considers the options for suspending obligations under the EU-ACP Economic Partnership Agreements (EPAs) in connection with violations of human rights, democratic principles or the rule of law following the expiry of the Cotonou Agreement in 2020. It outlines the functioning of the human rights clause in the Cotonou Agreement, before considering the possibilities for suspending the EPAs under their own provisions, or for other reasons in international law, such as countermeasures. Next, it discusses how any post-2020 arrangements can best continue the existing mechanisms for human rights conditionality set out in the Cotonou Agreement. In connection with this, this study proposes certain suggestions for improving future versions of human rights clauses, and considers whether there are legal obstacles to the invocation of this clause under general international law, principally under WTO law. The study concludes with a set of comments and recommendations.

Ekstern forfatter

Lorand BARTELS

Kommende begivenheder

06-04-2017
Impact of the Panama-Papers on Developing countries
Høring -
PANA
12-04-2017
Workshop: Implementation of the EU arms export control system
Workshop -
SEDE
12-04-2017
Workshop on the training of judges and legal practitioners
Workshop -
JURI LIBE

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