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Medical devices and in vitro diagnostic medical devices

10-05-2017

Medical devices and in vitro diagnostic medical devices cover a wide array of products. The EU legal framework for such devices was harmonised in the 1990s. The European Commission presented a pair of proposals for regulations in September 2012. Following Parliament's first readings in April 2014, the Council agreed its positions in October 2015. At the conclusion of the trilogues, agreement was reached on 25 May 2016. This was endorsed by the Council's Permanent Representatives Committee on 15 June ...

Medical devices and in vitro diagnostic medical devices cover a wide array of products. The EU legal framework for such devices was harmonised in the 1990s. The European Commission presented a pair of proposals for regulations in September 2012. Following Parliament's first readings in April 2014, the Council agreed its positions in October 2015. At the conclusion of the trilogues, agreement was reached on 25 May 2016. This was endorsed by the Council's Permanent Representatives Committee on 15 June and confirmed by Parliament's ENVI Committee on the same day. Both draft texts were adopted by the Council on 7 March 2017, and Parliament's second-reading vote on 5 April completed the adoption procedure. The regulation on medical devices will become fully applicable in May 2020, and that on in vitro diagnostic medical devices in May 2022.

Cross-Border Traffic Accidents in the EU - The Potential Impact of Driverless Cars

30-06-2016

Commissioned by the European Parliament’s Policy Department for Citizens’ Rights and Constitutional Affairs at the request of the JURI committee, this study provides an analysis of the potential legal impact of the introduction of connected and autonomous vehicles on rules of private international law determining jurisdiction and applicable law in the EU Member States in the event of a cross-border traffic accident. Following a case-studies approach, it makes a number of recommendations to improve ...

Commissioned by the European Parliament’s Policy Department for Citizens’ Rights and Constitutional Affairs at the request of the JURI committee, this study provides an analysis of the potential legal impact of the introduction of connected and autonomous vehicles on rules of private international law determining jurisdiction and applicable law in the EU Member States in the event of a cross-border traffic accident. Following a case-studies approach, it makes a number of recommendations to improve the legal framework. In line with recent EU law trends towards enhanced protection for the victims and given that products liability is likely to gain more importance in the area, the study suggests the introduction of a duty for car manufacturers to contract liability insurance covering traffic accidents victims; the possibility of a direct action against a manufacturer’s liability insurer and the establishment of a forum at the domicile of the victim for claims against manufacturers of cars using new technologies. In order to increase legal certainty, the study recommends to redefine the respective scopes of application of the two systems of private international law currently coexisting in the EU to determine the law applicable (the Rome II Regulation and the 1971 and 1973 Hague Conventions), and to apply Rome II in cases in which both the claimant and the defendant are domiciled in EU Member States. Finally, autonomous technologies may increase the difficulty to initiate extra-contractual liability claims therefore the study proposes that limitation periods be extended at the substantive law level or that a cumulative connecting mechanism be introduced at private international level for the benefit of the victims.

Medical devices and in vitro diagnostic medical devices

07-06-2016

Medical devices and in vitro diagnostic medical devices cover a wide array of products, from sticking plasters, to heart valves, to state-of-the-art analytical laboratory equipment, with over 500 000 devices on the EU market. The EU legal framework for such devices was harmonised in the 1990s. The European Commission presented a pair of proposals for regulations in September 2012, to update the framework. Following Parliament's first readings in April 2014, the Council agreed its positions in October ...

Medical devices and in vitro diagnostic medical devices cover a wide array of products, from sticking plasters, to heart valves, to state-of-the-art analytical laboratory equipment, with over 500 000 devices on the EU market. The EU legal framework for such devices was harmonised in the 1990s. The European Commission presented a pair of proposals for regulations in September 2012, to update the framework. Following Parliament's first readings in April 2014, the Council agreed its positions in October 2015. At the conclusion of the tenth trilogue meeting, agreement was reached on both proposals on 25 May 2016. The compromise centres on stricter requirements for notified bodies, stronger pre-market scrutiny and post-marketing surveillance; strengthened rules for high-risk devices and certain other categories of devices; and increased transparency and traceability. This updates a previous edition from December 2015: PE 572.819. A more recent edition of this document is available. Find it by searching by the document title at this address: http://www.europarl.europa.eu/thinktank/en/home.html

Planned obsolescence: Exploring the issue

02-05-2016

Although no overarching definition of planned obsolescence exists, the term 'planned obsolescence' (of products or technology) is described as the intentional production of goods and services with short economic lives, stimulating consumers to repeat purchases too frequently. The incandescent light bulb with an engineered shorter lifespan (the Phoebus cartel case) is one example from the past of proven planned obsolescence. Data suggest that the median lifespans of certain categories of product have ...

Although no overarching definition of planned obsolescence exists, the term 'planned obsolescence' (of products or technology) is described as the intentional production of goods and services with short economic lives, stimulating consumers to repeat purchases too frequently. The incandescent light bulb with an engineered shorter lifespan (the Phoebus cartel case) is one example from the past of proven planned obsolescence. Data suggest that the median lifespans of certain categories of product have been shortening, and consumer organisations have drawn attention to more recent suspected cases of planned obsolescence in connection with washing machines, inkjet cartridges, electronic devices, etc. One Member State – France – recently introduced a definition of planned obsolescence into its legislation, making it a punishable offence. No specific EU rules mention planned obsolescence, but the subject ties in with EU legislation on ecodesign, waste, use of natural resources, consumer information and the new package from the European Commission on the circular economy. The main consumer concerns and problematic strategies associated with the issue are: design features that do not allow repair, upgradability or interoperability with other devices; the unavailability of spare parts and high repair costs; and marketing strategies pushing consumers to buy new, fashionable products and replace existing ones very quickly. Various ways to curb the practice of planned obsolescence have been proposed, not least a shift towards a culture that values product durability and sustainability.

Contracts for online and other distance sales of goods

15-02-2016

In December 2015, the Commission proposed a directive on contracts for online and other distance sales of goods (online sale of goods directive). This would partly replace the existing Consumer Sales Directive with regard to distance sales (both online and offline). Unlike the Consumer Sales Directive, the proposed online sale of goods directive would provide for maximum (total) harmonisation, thereby prohibiting Member States from introducing a higher level of consumer protection within the scope ...

In December 2015, the Commission proposed a directive on contracts for online and other distance sales of goods (online sale of goods directive). This would partly replace the existing Consumer Sales Directive with regard to distance sales (both online and offline). Unlike the Consumer Sales Directive, the proposed online sale of goods directive would provide for maximum (total) harmonisation, thereby prohibiting Member States from introducing a higher level of consumer protection within the scope of the directive. A more recent edition of this document is available. Find it by searching by the document title at this address: http://www.europarl.europa.eu/thinktank/en/home.html The proposed online sale of goods directive is part of the Digital Single Market Strategy, and comes alongside several other proposed legal instruments, notably the digital content supply directive [2015/0287(COD)] and the portability of digital content directive. Although, legally speaking, the proposal is new, in political terms it aims to replace the 2011 proposal for a Common European Sales Law, in line with the commitment made by the Juncker Commission in December 2015.

Circular economy 1.0 and 2.0: A comparison

22-01-2016

When withdrawing the July 2014 circular economy package, the Commission pledged to put forward 'a more ambitious proposal.' The new package presented in December 2015 retains many elements from the initial one. Differences include somewhat lower waste-management targets, a weaker focus on food waste, and more detailed measures enabling a shift to a circular economy.

When withdrawing the July 2014 circular economy package, the Commission pledged to put forward 'a more ambitious proposal.' The new package presented in December 2015 retains many elements from the initial one. Differences include somewhat lower waste-management targets, a weaker focus on food waste, and more detailed measures enabling a shift to a circular economy.

Circular economy package: Four legislative proposals on waste

22-01-2016

Although waste management in the European Union (EU) has improved considerably in the past decades, almost a third of municipal waste is still landfilled and less than half is recycled or composted, with wide variations between Member States. Improving waste management could deliver positive effects for the environment, climate, human health and the economy. As part of a shift in EU policy towards a circular economy, the European Commission made four legislative proposals introducing new waste-management ...

Although waste management in the European Union (EU) has improved considerably in the past decades, almost a third of municipal waste is still landfilled and less than half is recycled or composted, with wide variations between Member States. Improving waste management could deliver positive effects for the environment, climate, human health and the economy. As part of a shift in EU policy towards a circular economy, the European Commission made four legislative proposals introducing new waste-management targets regarding reuse, recycling and landfilling. The proposals also strengthen provisions on waste prevention and extended producer responsibility, and streamline definitions, reporting obligations and calculation methods for targets. As the Parliament and Council begin their consideration of the proposals, stakeholders are divided. A more recent edition of this document is available. Find it by searching by the document title at this address: http://www.europarl.europa.eu/thinktank/en/home.html

Medical devices and in vitro diagnostic medical devices

07-12-2015

Medical devices and in vitro diagnostic medical devices cover a wide array of products, from sticking plasters, to heart valves, to state-of-the-art analytical laboratory equipment, with over 500 000 devices on the EU market. The EU legal framework for such devices was harmonised in the 1990s. The European Commission presented a pair of proposals for regulations in September 2012, to update the framework. Following Parliament's first reading in April 2014, the Council agreed its position in October ...

Medical devices and in vitro diagnostic medical devices cover a wide array of products, from sticking plasters, to heart valves, to state-of-the-art analytical laboratory equipment, with over 500 000 devices on the EU market. The EU legal framework for such devices was harmonised in the 1990s. The European Commission presented a pair of proposals for regulations in September 2012, to update the framework. Following Parliament's first reading in April 2014, the Council agreed its position in October 2015. Interinstitutional negotiations are under way, with trilogue meetings having taken place on 13 and 28 October, on 11 and 28 November, and on 3 December. Stakeholders generally welcome the progress made, with industry asking for the elimination of burdensome requirements, and patient and consumer associations stressing the need for information. A more recent edition of this document is available. Find it by searching by the document title at this address: http://www.europarl.europa.eu/thinktank/en/home.html

The Cost of Non-Europe in the Single Market. Part V - Consumer Acquis

02-10-2014

Cost of Non-Europe Reports identify the possibilities for economic or other gains and/or the realisation of a ‘public good’ through common action at EU level in specific policy areas and sectors. This Cost of Non-Europe Report seeks to analyse the costs for citizens, businesses and relevant stake-holders of remaining gaps and barriers in the European Single Market, building on and updating the 1988 Cecchini Report, which quantified its potential benefits.

This particular study - the fifth in a ...

Cost of Non-Europe Reports identify the possibilities for economic or other gains and/or the realisation of a ‘public good’ through common action at EU level in specific policy areas and sectors. This Cost of Non-Europe Report seeks to analyse the costs for citizens, businesses and relevant stake-holders of remaining gaps and barriers in the European Single Market, building on and updating the 1988 Cecchini Report, which quantified its potential benefits.

This particular study - the fifth in a series - analyses the gaps in European consumer legislation. It provides a qualitative appreciation of the existing legislation, identifying areas where further EU legislative action could be beneficial, and provides tentative estimates of the costs of failure to legislate. It is not intended as comprehensive quantification, but rather as a ‘snap shot’ of some benefits which could be attained through completion of the consumer acquis.

Autor externo

Mark Peacock (GHK Int.)

Consumer Product Safety Regulation: Detailed Appraisal of the European Commission's Impact Assessment

04-04-2014

This paper seeks to provide a detailed analysis, from a methodological perspective, of part of the European Commission's Impact Assessment (IA) accompanying its proposal for a Consumer Product Safety Regulation (CPSR). Requested by the IMCO Committee, the aim of this analysis is to determine whether the IA covered adequately the following elements of the Commission's proposal: Country of origin marking (Article 7 of the CPSR) and obligations for economic operators (Articles 8 to 11 of the CPSR). ...

This paper seeks to provide a detailed analysis, from a methodological perspective, of part of the European Commission's Impact Assessment (IA) accompanying its proposal for a Consumer Product Safety Regulation (CPSR). Requested by the IMCO Committee, the aim of this analysis is to determine whether the IA covered adequately the following elements of the Commission's proposal: Country of origin marking (Article 7 of the CPSR) and obligations for economic operators (Articles 8 to 11 of the CPSR). It performs the requested 'health check' from two angles. Firstly, it analyses whether the Commission's IA - with regard to the above subjects only - is fit for its overall purpose, which is to aid political decision-making by presenting a comprehensive assessment of the likely impacts of all options. Secondly, it analyses whether the IA meets the standards which the Commission has laid down in its internal Impact Assessment Guidelines, as well as the quality criteria which the Parliament has defined in its resolutions.

Futuros eventos

26-10-2020
European Gender Equality Week - October 26-29, 2020
Outro evento -
FEMM TRAN LIBE BECA AIDA INTA CULT EMPL DROI SEDE DEVE
26-10-2020
Joint LIBE - FEMM Hearing on Trafficking in human beings
Audição -
LIBE FEMM
27-10-2020
Hearing on Rebuilding fish stocks in the Mediterranean: next steps
Audição -
PECH

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