Tag Archives: Changes to EU Device Law

Are Wearables Medical Devices Requiring a CE-Mark in the EU?

Wearable watches that help consumers obtain a better understanding of their eating patterns; wearable clothes that send signals to treating physicians; smart watches: they are but a few examples of the increasingly available and increasingly sophisticated “wearables” on the EU market. These technologies are an integrated part of many people’s lives, and in some cases … Continue Reading

EU Vote on First Borderline Decision Confirms: Cranberry Products Are Not Medical Devices

The EU Regulatory Committee on Medical Devices recently voted in favor of the European Commission’s draft decision on the classification of cranberry products (the “Cranberry Decision”).  In essence, the Cranberry Decision provides that cranberry products intended to prevent or treat cystitis and that have a principal intended action based on proanthocyanidins (“PACs”) do not fall … Continue Reading

EU Medical Devices Regulation Series: Interpreting the “Industrial Scale” Concept

The term “industrial scale” appears twice in the draft EU Medical Devices Regulation (“MD Regulation”) in relation to so-called “in-house devices.” The term equally appears in the draft in-vitro diagnostic medical devices (“IVD”) Regulation. To provide perspective on the meaning of “industrial scale” and how the draft MD Regulation’s use of the term may be … Continue Reading

EU Medical Devices Regulation Series on Key Issues

It has been fairly quiet since the political agreement was reached last June on the EU Medical Devices Regulation (“the Regulation”). While the Commission’s lawyer-linguists iron out the final language, paving the way for formal adoption in the coming months, we are preparing a series of articles, beginning with this blog post, to address key … Continue Reading

Transparency and Conflicts of Interest: France Heading Towards Additional Healthcare Reforms

Over the past few years, several scandals (e.g., Poly Implant Prothèse (“PIP”) breast implants, Mediator weight-loss drug, etc.) have tarnished the public perception of France’s healthcare sector and raised serious questions about the independence of medical decision-making by practitioners.  As it sets a new course, France is now at the European forefront of increasing the … 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

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

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

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

Proposed EU Rules Impact Commercial Testing Laboratories

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 rules, laboratory-developed tests (colloquially known as “home … Continue Reading

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

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 Council for their consideration. At … Continue Reading