This post originally appeared on our sister blog, InsideMedicalDevices. The Court of Justice of the European Union (CJEU) has recently ruled that products which fall within the definition of a medical device, but are not intended by their manufacturer to be used for a “medical purpose,” do not fall within the scope of the Medical … Continue Reading
This post originally appeared on our sister blog, InsideMedicalDevices. The European Commission has proposed a revision to the regulatory framework for in vitro diagnostic medical devices (IVDs) that could have a significant impact on the operations of commercial laboratories in the EU or those offering testing services to customers in the EU. Laboratory-Developed Tests Under current EU … Continue Reading
This post originally appeared on our sister blog, InsideMedicalDevices. The publication by the European Commission of two proposals for the revision of the EU regulatory framework for medical devices in September has initiated the legislative process which will ultimately lead to the adoption of the final EU Regulations on medical devices. The proposals have been transmitted to the European Parliament and … Continue Reading
This post originally appeared on our sister blog, InsideMedicalDevices. On September 26, 2012 the European Commission adopted its long awaited proposals for the revision of the EU regulatory framework for medical devices. Three Directives, i.e., Directive 90/385/EEC on active implantable medical devices, Directive 93/42/EEC on medical devices and Directive 98/79/EC on in vitrodiagnostic medical devices (IVDs), will … Continue Reading
Originally published as Covington E-Alert on October 3, 2012 French Law No 2011-2012 of 29 December 2011 on the Strengthening of Health Protection for Medicinal and Health Products has been inserted into the Public Health Code (‘Code de la santé publique’ or CSP). It includes new advertising rules for medical devices (MDs) and in vitro … Continue Reading
Originally published as Covington E-Alert on September 26, 2012 Today the European Commission published its long awaited proposals for the revision of the EU regulatory framework for medical devices. Three Directives, i.e., Directive 90/385/EEC on active implantable medical devices, Directive 93/42/EEC on medical devices and Directive 98/79/EC on in vitro diagnostic medical devices (IVD) will … Continue Reading
Article originally published in European Pharmaceutical Contractor, September 2012 Although at first sight the rules that govern the distinction between medical devices and medicines in the EU allow for a direct and systematic approach, borderline determinations are, in practice, often difficult and the rules lack logical rigour The European Commission is expected to publish proposals … Continue Reading
Originally published as Covington E-Alert on February 13, 2012 New Advertising Rules Medicinal and Health Products (“loi relative au renforcement de la sécurité sanitaire du médicament et des produits de santé”) (the ‘New Law’) will have a tremendous impact on the medical devices industry. The industry will now be subject to new advertising rules, sunshine-like … Continue Reading
Originally published as Covington E-Alert on January 20, 2012 Law No 2011-2012 of 29 December 2011 on the Strengthening of Health Protection for Medicinal and Health Products (“loi relative au renforcement de la sécurité sanitaire du médicament et des produits de santé”) (the “New Law”),creating Articles L. 1453-1 and L. 1454-3 to L. 1454-5 of … Continue Reading
Article originally published in the In Vitro Diagnostics: The Complete Regulatory Guide (Chapter (8) with permission from FDLI), 2010 I. Introduction This chapter discusses the European Union (EU) regulation of in vitro diagnostic (IVD) medical devices, covering both pre- and postmarket regulatory requirements. In order to understand these rules and the manner in which they … Continue Reading
Article originally published in RAJ Devices, September/October 2009 The UK government in 2004 asked Philip Hampton, a leading businessman, to lead a review of regulatory inspection and enforcement across a number of the country’s regulatory agencies. The report of the review, called the Hampton Report, was published in March 2005 and set out an ambitious … Continue Reading
Article originally published in EURALex in October 2008 The reprocessing of medical devices has been an increasing industrial practice since the late 1970s. While reprocessing of some medical devices has taken place within hospitals for many years, the market for professional third-party reprocessing service providers has developed during the last decade due to financial pressures … Continue Reading
Article originally published in RAJ Pharma in July 2008 By 2015 nanotechnology-based medicines and medical devices are expected to flood the global market. Brian Kelly and Peter Bogaert discuss the regulatory and legal implications of medical nanotechnology in Europe. Nanotechnologies are the design, characterisation, production and application of structures, devices and systems by controlling shape and size … Continue Reading
