Tag Archives: Borderline

EU Medical Devices Regulation Series: Potential for Easing Borderline Determinations?

Earlier this week, in a plenary vote, the EU Parliament endorsed the texts of the Regulation on Medical Devices (the “Regulation”—latest version available here) and the parallel Regulation on In-Vitro Diagnostic Medical Devices (the “IVD Regulation”—latest version available here).  This presents a good opportunity to have a closer look at one of the essential questions … 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

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

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

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
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