medical devices

Medical Devices proposal: more than 1,000 amendments to be discussed

More than 1,000 amendments will be discussed today (29 May) during the European Parliament’s Committee on Environment, Public Health and Food Safety (ENVI) meeting on the proposals for a Medical Devices Regulation and the In Vitro Diagnostic Medical Devices Regulation. An overview of key issues is provided below. On 3 and 12 April 2013, the European Parliament’s Committee on Environment, Public Health and Food Safety (ENVI) published two draft reports amending the (...)

Public consultation on Declaration of Helsinki on medical research involving human subjects

A two-month public consultation (15 April to 15 June 2013) on the World Medical Association’s Declaration of Helsinki on medical research involving human subjects has been launched by the World Medical Association. A revised version of the Declaration is available on the WMA website. This consultation is of particular interest in the context of the ongoing revision of the Clinical Trials legislation. Please click here for detailed information on the consultation process The (...)

[Update] EPHA briefing on cyber security and health technologies

Below is an updated version of the EPHA briefing on cyber security and health technologies, first published in September 2012, taking account of developments and further EPHA work since then. As noted in the EPHA briefing on data protection reform, the immediate problem presented by these technologies is the threat to privacy and the protection of personal information. However, the security risk presented – be it through malfunction or deliberate attack – is less widely (...)

Medical Devices at EU Socialists & Democrats Workshop: an evolving debate

On 19 March 2013 a workshop on medical devices took place in the European Parliament to continue discussions over the legislative proposal presented by the European Commission in September 2012. The workshop was organised by the S&D Group (Group of the Progressive Alliance of Socialists and Democrats in the European Parliament) and was chaired by the Rapporteur for the Medical Devices report, Dagmar Roth-Behrendt MEP (Germany, S&D). The discussion over the two proposals on Medical (...)

EU’s new cyber security legislation struggles in European Parliament

At the beginning of 2013 the European Commission launched two major initiatives on cyber security - the EU Cyber Security Strategy and a proposal for a Directive on network and information security. Concerns have been raised about both initiatives and recent reports suggest that the Directive may not make it through the European Parliament’s current legislature, as previously hoped. A report by EurActiv (a website devoted to EU affairs) quoting a number of administrators from within (...)

Ireland’s Presidency Health Priorities presented

Ireland, in collaboration with its TRIO partners - Lithuania and Greece - has made a commitment to use its resources to prioritise solid progress on a number of key legislative dossiers in health and calls on member states to work together, sharing ideas, information and best practice. The Irish Presidency Programme, whose cornerstone is progressing the legislative agenda, contains a series of health priorities: on 23 January 2013 the Irish Minister of Health, James Reilly, presented them (...)

EU launches centre to fight cyber crime against critical infrastructures

11 January 2013 saw the inauguration of the EU’s new European Cyber Crime Centre - the EC3. Hosted by Europol and based in The Hague, the centre will form a focal point for the fight against cyber crime in the EU and coordination with other bodies and departments, including the U.S. Federal Bureau of Investigation (FBI). The Centre is the latest in a string of measures enacted at the European level to fight this new trend in criminal activity. Cyber crime affects health in a number (...)

European Commission publishes results of public consultation on Health Technology Assessment (HTA)

In December 2012 the European Commission released the results of its public consultation on stakeholder involvement in Health Technology Assessment (HTA), as envisaged by the Directive on patients’ rights in cross-border healthcare. Article 15 of Directive 2011/24/EU on the application of patient rights in cross-border healthcare provides for the establishment of a permanent, voluntary Health Technology Assessment (HTA) network in the EU, connecting national authorities and bodies (...)

EPHA Position on Medical Devices Revision

Following the Commission proposals for a Regulation on Medical Devices and on In Vitro Medical Devices released in September 2012, EPHA has developed a position paper highlighting, inter alia, the importance of the provisions related to patient safety; the responsibilities of the notified bodies, and improved traceability. The EPHA Position on Medical Devices is supportive of the objectives - and legal format - of the Commission’s proposal which aims at ensuring a high level of human (...)

[EPHA Briefing] Cyber Security and Health Technologies

This briefing outlines the ways in which technological advances are rapidly changing the delivery of health services and examines the threats posed to security in the face of malfunction and/or deliberate attack. As noted in the EPHA briefing on data protection reform, the immediate problem presented by these technologies is the threat to privacy and the protection of personal information. However, the security risk presented – be it through malfunction or deliberate attack – (...)