Tag Archives: Medical Devices

Another round of upcoming amendments to the medicines laws in Germany – Clinical Trials, Advertising, Biologics and more…

On 11 November 2016, the German Parliament passed another new law amending different parts of the German Medicines Act (Arzneimittelgesetz) and the Act on Advertising for Healthcare Products (Heilmittelwerbegesetz). The law is titled “Viertes Gesetz zur Änderung arzneimittelrechtlicher und anderer Vorschriften“. The draft was deliberated in the health committee of the Federal Council (Bundesrat) on … Continue Reading

EU Agreement on a General Approach on the Medical Devices Package

This article was originally posted on our sister blog Inside Medical Devices On October 5, 2015, after three years of continued discussions and negotiations on the modernization of EU medical devices and IVD rules, the Council of Ministers of the EU countries (“the Council”) agreed on a full General Approach on the review of the … Continue Reading

European Court to Clarify Responsibilities and Liability for Medical Devices

A more detailed analysis of the impact of the work at the CJEU is featured in Clinica Medtech Intelligence. Liability Spotlight now on the Notified Bodies Background and Context The so-called PIP-Breast-implant scandal now reaches the Court of Justice of the European Union (CJEU). As last week a German court referred a liability case to … Continue Reading

Germany Headed to Stricter Criminal Laws Against “Corruption In The Healthcare Sector”

On 4 February 2015, the German Ministry of Justice published a new draft law specifically aimed to combat corruption in the healthcare sector. Key element of the draft legislation will be a newly defined criminal offence that will be inserted as a new Section 299a of the German Criminal Code (StGB). This new criminal offence … Continue Reading

Commission Updates EU Medical Devices Borderline Manual

The European Commission’s Borderline and Classification Medical Devices Expert Group has published a new version of its Manual on Borderline and Classification in the Community Regulatory Framework for Medical Devices.  The updated manual includes a new section on software and mobile applications reflecting the growing industry of medical device software.  The manual also provides new … 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

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

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

What’s in a Name?

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

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
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