Archives: Medical Devices

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New MHRA Guidance on Borderline Medical Devices

In February 2014, the MHRA published new guidance on borderline medical devices.  The guidance considers only medical devices within the terms of the Medical Device Directive and not the Active Implantable Medical Devices Directive or In Vitro Medical Devices Directive. Purpose and mode of action The MHRA makes clear that borderline determinations “will be based on the stated intended purpose of … Continue Reading

International Consensus on “Software as Medical Device” Definition

Last month, the International Medical Device Regulators Forum (IMDRF) reached a consensus on a potentially key aspect of the future regulation of medical software in the US, the EU, Brazil, Canada and Japan, that is, a harmonized definition of when stand-alone software will be considered to be a medical device. This category of software, dubbed … Continue Reading

Call for expression of interest to participate in early dialogue between HTA bodies and healthcare product developers

A call for expression of interest addressed to healthcare product developers who would be interested in engaging in early dialogues (EDs) with Health Technology Assessment (HTA) bodies was launched in December 2013 and will stay open until October 2014.  The call concerns developers of both medicinal products and medical devices. The European Commission defines HTA … Continue Reading

Privacy Impact Assessments – Soon Compulsory for Companies in the Life Sciences Industry?

Privacy Impact Assessments (PIAs) or  data protection impact assessments used to be discussed in the context of specific technologies or industry sectors (see, for instance, the European Commission’s recommendations in relation to  applications supported by radio-frequency identification (RFID) and the development of smart grids). However, this situation is about to change. PIAs are increasingly being promoted by … Continue Reading

French Sunshine Rules and the Medical Devices Industry

This post originally appeared on our sister blog, InsideMedicalDevices.   At the end of May 2013, the French government released the long awaited Decree implementing the 2011 French Sunshine Act.  The Decree requires companies to publicly disclose — in French — any benefit over 10 Euros and agreements (except commercial ones) concluded with healthcare professionals or other actors active in the … Continue Reading

Lead Member of the European Parliament Proposes a Pre-Marketing Authorization System

This post originally appeared on our sister blog, InsideMedicalDevices.   As announced in our previous post, the rapporteur (i.e., the leader of the parliamentary process) for the new Regulation on medical devices, Mrs. Dagmar ROTH-BEHRENDT, has proposed the introduction of a pharma-like pre-marketing authorization regime for high risk medical devices in the EU. In her recent report submitted to the ENVI Committee of the European Parliament (the parliamentary committee … Continue Reading

Spain: Proposed New Legislation on Clinical Trials

The Spanish Ministry of Health has published a draft Royal Decree on Clinical Trials, which the Spanish government is expected to adopt by the end of this year.  Once adopted, the new Royal Decree will replace Royal Decree 223/2004 on Clinical Trials and will regulate all clinical trials with medicines and medical devices in Spain. … Continue Reading

Advocate General Opinion on Reclassification of Medical Devices

On May 30, 2013, Advocate General Sharpston delivered an opinion on a request for a preliminary ruling from the Finnish national courts concerning the laws governing reclassification of medical devices (Advocate General: Opinion, Case C-109/12).  The Advocate General’s opinion does not bind the Court of Justice of the European Union (CJEU).  However, in the majority … Continue Reading

Commission Recommendation on Unique Device Identification System in the EU

On 5 April, 2013 the European Commission adopted a recommendation on a common framework for a unique device identification (UDI) system in the EU. The hope is that a harmonized UDI system will facilitate device safety monitoring and reporting, recalls and other field safety corrective actions. It will also help avoid device-related medical errors and injuries … Continue Reading

“Notified Bodies” Under EU Device Regulations: Under Stricter Control But With More Power

This post originally appeared on our sister blog, InsideMedicalDevices. Unlike in the US, medical devices in the EU are not subject to a premarket authorization by a competent authority but instead to a conformity assessment procedure.  For low-risk devices, the manufacturer conducts this conformity assessment procedure, whereas for medium and high risk devices, independent third parties, so-called “Notified … Continue Reading

EU Proposes a Scrutiny Procedure for High-Risk Devices

This post originally appeared on our sister blog, InsideMedicalDevices. Following recent developments regarding breast implants and metal-on-metal hip joint replacements, the European Parliament (EP) adopted a resolution calling for safer medical devices and the introduction of a marketing authorization system for high-risk devices.  While the Commission has not endorsed the EP’s resolution for a premarket authorization system in its Proposal for a new EU medical devices’ … Continue Reading

New UK Guidance for Doctors on Prescribing Medical Devices and Medicines

This post originally appeared on our sister blog, InsideMedicalDevices. The General Medical Council in the UK has issued new prescribing guidance for doctors that includes detailed provisions on prescribing medical devices and managing patients using medical devices. The GMC’s previous guidance was focused almost exclusively on medicines.  The new guidance recognizes that medical devices — particularly software-based devices … Continue Reading

Innovation vs. Safety: The New Proposed Rules for Medical Devices in the European Union

Article originally published in the FDLI Update (January/February 2013) “Being able to use innovative products at the earliest possible time – and in Europe we deliver innovation about three years before our American counterparts with their own system – is a benefit to patients that we cannot put aside.” This is how former European Union … Continue Reading

Proposed EU Rules Impact Commercial Testing Laboratories

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

New Regulations for Medical Devices in Europe: Overview of the Legislative Process

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

New EU Regulations for Medical Devices and IVDs

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

France – Prior Approval for Advertising for Medical Devices and IVDs

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

New Medical Devices Regulations in the EU – Significant Changes But No Big Bang

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

France – A Revolution for the Medical Devices Industry

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

European Union Regulation of In Vitro Diagnostic Medical Devices

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

No More Red Tape: MHRA Awaits Tougher Sanctioning Powers in the UK

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

Product Liability and Reuse of Medical Devices

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

Global Harmonization Is Not All That Global: Divergent Approaches in Drug Safety

Article originally published in the Food and Drug Law Journal (with permission from FDLI), August 2008 I. INTRODUCTION Pharmacovigilance is a global public health activity that is currently undergoing a considerable amount of regulatory, social and political change. The standards expected by society have been raised following high-profile product withdrawals. Industry, regulatory authorities and consumers … Continue Reading
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