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Ramon Luque

Ramon Luque is special counsel in Covington’s International Arbitration Practice. Ramon represents clients in high-stakes commercial and investor-state disputes worldwide, with a focus on disputes in Africa, the Middle East, and Asia, in recent years. His experience spans a broad range of industry sectors, including energy, mining, construction, life sciences, and media and entertainment. He is familiar with both ad hoc proceedings, and arbitrations conducted under the ICC, LCIA, SIAC, and UNCITRAL Rules, among others.

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On 15 July 2016, the European Commission updated MEDDEV 2.1/6 (the “MEDDEV Guidance), its medical device guidance on the qualification and classification of stand alone software used in the healthcare setting. The updated version replaces an earlier version of MEDDEV 2.1/6 issued by the European Commission in January 2012.

MEDDEV 2.1/6 generally stands as a valuable resource to assist software developers in the assessment of whether software is a medical device. However, some have expressed disappointment that the updated guidance did not go further in clarifying the picture, particularly those operating within the mobile health (mHealth) space.

Indeed, the main changes consist of additions to the definitions section of the MEDDEV Guidance. There is now a definition to clarify that “software” is a “set of instructions that processes input data and creates output data“. There are also accompanying definitions of “input data” and “output data”.
Continue Reading EU Updates MEDDEV 2.1/6 Guidance on Standalone Software