Archives: Device Regulation in Europe

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International Consensus on “Software as Medical Device” Definition

Last December, 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

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 … Continue Reading

Transfer of Responsibility of Certificates of Free Sale for UK Medical Devices Scheme

With effect from 1 April 2014, the UK Government is proposing to transfer responsibility for the Certificates of Free Sale (CFS) for medical devices scheme from the UK Department of Health to the UK Medicines and Healthcare Products Regulatory Agency (MHRA).  The UK Government issued a consultation relating to the proposed transfer, which closed on … Continue Reading

French Court Finds Notified Body Liable in Breast Implants Scandal

On November 14, 2013, the Toulon Commercial Court found TÜV Rheinland liable towards victims of the PIP (Poly Implant Prothèse) scandal.  The Court concluded that TÜV Rheinland had been negligent in carrying out its duties as a “notified body,” a key element of the European medical devices regulatory framework.  This in turn allowed PIP, a … Continue Reading

EU Device Regulatory Reforms a Step Closer

In a landmark step, the European Parliament approved a package of reforms to the European Commission’s proposal for a Regulation on medical devices and a Regulation on in vitro diagnostic medical devices on 22 October 2013.  During the plenary vote, the European Parliament adopted most of the amendments that the Environment, Public Health and Food … Continue Reading

UK NICE Considers Restrictions on Hip Replacement Implants

The UK National Institute for Health and Care Excellence (NICE) has issued draft guidance recommending tightening standards for hip replacement devices.  If adopted, the tougher standards could force the National Health Service (NHS) to stop using a significant number of existing devices, with obvious impacts on manufacturers of these products.… Continue Reading

Ruling on Product Classification Highlights Lack of Harmonization in the EU

On 3 October 2013, the Court of Justice of the European Union (CJEU) delivered its judgment in case C-109/12 concerning the legal status of medical devices.  The CJEU confirmed Advocate General Sharpston’s opinion (see our previous post) that Member States may classify the same product differently and that if they reclassify a device as a … Continue Reading

Stricter and Clearer Rules for Notified Bodies in the EU

The European Commission has recently adopted new measures as part of the Joint Plan of immediate actions intended to restore patient and professional trust in medical devices and improve their safety, after events like the French breast implant scandal have shaken up the industry. Both initiatives, adopted on 24 September 2013, aim at clarifying and … Continue Reading

More Delays for the Vote on the New EU Regulations for Medical Devices and IVDs

The long awaited vote by the Environment, Public Health and Food Safety (ENVI) Committee, the lead European Parliament Committee overseeing the revision of EU medical devices legislation, on the European Commission’s proposals for a Regulation on medical devices and a Regulation on in vitro diagnostic medical devices has been delayed for a second time.  In … Continue Reading

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

As discussed in our previous post on our sister blog Inside EU LifeSciences, 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, … Continue Reading

French Sunshine Rules and the Medical Devices Industry

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 health sector in France. … Continue Reading

New UK Tracking System for High-Risk Devices in Development

The Medicines and Healthcare products Regulatory Agency (MHRA) announced on June 7, 2013 that four National Health Service hospitals have agreed to pilot a new tracking system for high-risk medical devices.  The system is one of 11 projects established by the Agency to strengthen the regulation of medical devices following a government review into the problems … 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 of … Continue Reading

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

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 … Continue Reading

Commission Recommendation on Unique Device Identification System in the EU 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 … Continue Reading

EU Regulation on Electronic Instructions for Use of Medical Devices

Commission Regulation (EU) 207/2012 on electronic instructions for use of medical devices (the Regulation) came into force in the EU last month.  The Regulation allows manufacturers of certain types of medical devices and accessories to replace paper form instructions of use with an electronic substitute.  It aims to reduce environmental burden and improve the competitiveness … Continue Reading

EU to Debate Establishing a Pre-Marketing Authorization System for High Risk Devices

One of the most critical issues of the ongoing revision of the EU legislation on medical devices is whether the new rules will contain a pharma-like pre-marketing authorization regime for high risk medical devices that requires a review by a governmental regulatory authority rather than a notified body. The question is subject to intensive debate … Continue Reading

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

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 Bodies,” are involved. What are Notified … Continue Reading

EU Device Regulation Introduces Harmonized Traceability and Transparency Requirements to Improve Patient Safety

Eucomed, the association representing the European medical technology industry, estimates that approximately 500,000 different medical devices are currently available in the EU.  However, no precise data exist on the number, the types and the approval status of medical devices on the European market, let alone the evidence supporting their use and the conformity assessment they … Continue Reading

New UK Guidance for Doctors on Prescribing Medical Devices and Medicines

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 and remote monitoring devices — are … Continue Reading

EU Proposes a Scrutiny Procedure for High-Risk Devices

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

EU Device Regulation Seeks to Enhance Legal Certainty Through Clarified Scope and EU-wide Classification of “Borderline” Products

The application of different regulatory regimes to so-called “borderline” products and regulatory gaps for certain products compromise both the protection of patient safety and the creation of the internal market in the European Union.  The European Commission has proposed a revision to the regulatory framework for medical devices that aims to increase the legal certainty … Continue Reading

CJEU Clarifies Medical Device Borderline

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 Devices Directive 93/42/EEC (MDD). Case C-219/11 Brain Products GmbH … Continue Reading