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Ramon Luque

Ramon Luque is special counsel in Covington’s International Arbitration Practice Group. Ramon represents and counsels clients in a wide range of complex and international commercial and investor-state matters. He draws on his experience from both ad hoc proceedings, and arbitrations governed by ICC, LCIA, DIFC-LCIA, and ICSID rules, among others, as well as experience in substantial English litigation matters. He is particularly experienced in advising clients in the energy sector in relation to disputes involving oil and gas, LNG, and power assets, and also has significant experience advising clients in a number of other sectors.

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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